New Drug Approval Fee Raised to 410 Million Won... "Increasing Staff to Shorten Review Period"

MFDS Announces Administrative Notice on Pharmaceutical Approval Regulations
Approval Fee for Newly Developed Medical Devices Reduced from 1.49 Million to 9.8 Million KRW

The Ministry of Food and Drug Safety (MFDS) has decided to increase the personnel for new drug approvals and shorten the review period. The new drug approval fee, which was previously 8.83 million KRW, will be significantly raised to 410 million KRW.

The MFDS announced on the 9th the administrative notice of the amendment to the "Regulations on Fees for Approval of Pharmaceuticals, etc.," which fully applies the beneficiary pays principle to support the 'New Drug Approval Innovation Plan' aimed at accelerating new drug development.

The new drug approval fee of 410 million KRW consists of 260 million KRW for personnel costs related to the approval review per new drug, 130 million KRW for associated expenses, and 20 million KRW for general administrative costs.

The amendment also includes shortening the new drug approval period from the existing 420 days to 295 days.

Based on the significant fee increase, the MFDS plans to operate dedicated review teams composed of reviewers specialized in manufacturing, quality, and other fields to provide expert consultations at each approval stage to the industry, and prioritize reviews of clinical trials and Good Manufacturing Practice (GMP).

Additionally, to strengthen regulatory capabilities, the proportion of expert reviewers such as specialized doctors and pharmacists will be increased from the current 31% to over 70%, and the number of tailored face-to-face consultation meetings for regulatory support will be expanded from 3 to more than 10 sessions.

The MFDS explained that this fee adjustment aims to bring the fees to a global level, considering that the U.S. Food and Drug Administration (FDA) charges approximately 5.3 billion KRW and the European Medicines Agency (EMA) charges about 490 million KRW for new drug approvals.

Furthermore, a 50% fee reduction will be applied to new drugs submitted by domestic small and medium-sized enterprises (SMEs), and a 90% reduction will be granted for cases where already approved new drugs apply for dosage changes or additional injectable containers.

The approval application fee for newly developed medical devices will also be significantly increased from 1.49 million KRW to about 98 million KRW. However, the average approval period will be shortened from 300 days to within 230 days, and a 50% fee reduction will be applied to products submitted by SMEs.