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 ▲ the implementation of a new drug approval innovation plan ▲ reform of the GMP evaluations ▲ 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 wil