The Ministry of Food and Drug Safety has announced an amendment to the “Fee Regulations for the Approval of Drugs, etc.” that will significantly increase the fee for new drug approvals from KRW 8.83 million to KRW 410 million. This is the first time in 4 years that the government has decided to increase the new drug approval fee, which is in line with the previous four-year cycle fee hike. In 2016, the fee was raised from KRW 6.82 million to KRW 8.83 million in 2020, and this time in 2024, another 4 years later, the fee is being raised to KRW 410 million.

The MFDS’s fee hike announcement was received with surprise in the industry. The MFDS had been conducting a study to increase the fee for new drug