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  • Changes made to the drug approval system in the new year
  • by Lee, Hye-Kyung | translator Alice Kang | Jan 2, 2025 06:11am
New drug approval fee rises, GMP evaluation system reform
Written inspection results will be recognized for triennial inspections of drug manufacturing sites
Various changes will be made to the drug approval and management system in the new year of 2025, including the new drug approval innovation plan.

On December 31st, the Ministry of Food and Drug Safety (MFDS) announced the changes that will be enforced from January, including ¡ã the implementation of a new drug approval innovation plan ¡ã reform of the GMP evaluations ¡ã recognition of written inspection results during the triennial inspection of drug manufacturing sites.


With the implementation of the new drug approval and review innovation process from January 1 next year, a new drug approval application fee of KRW 410 million will be charged.

The increased fee will be used to establish a dedicated team fo
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