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  • [Reporter's View] KRW 400m drug approval fee
  • by Lee, Hye-Kyung | translator Hong, Ji Yeon | Feb 12, 2025 06:13am
Shortened approval duration put to test
Now, the new drug approval fee in South Korea costs KRW 410 million. On September 9th, 2024, the Ministry of Food and Drug Safety (MFDS) issued an administrative notice of 'Revision to the Regulation of Fees for Pharmaceutical Approval.' The revision specifies details of increasing the new drug approval fee to KRW 410 million and reducing the approval duration from 420 days to 295 days, effective January 1st of this year.

The industry draws attention to the first product to pay a significant fee hike. The approval fee of KRW 410 million includes a preliminary consultation session prior to the submission of the application for marketing approval. Once the application is submitted, a task force team is assigned. It
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