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Korea Republic: Proposed amendment to the “Regulations on Fees for Pharmaceutical Approval, etc.”

Updated on : 21-09-2025

Korea Republic: Proposed amendment to the “Regulations on Fees for Pharmaceutical Approval, etc.”

The Ministry of Food and Drug Safety (MFDS) is amending the “Regulations on Fees for Pharmaceutical Approval, etc.” as follows:A. Increase in application fees for biosimilar products approval and preliminary review (3 and 26 of Annex 1 in the Draft) The fees that have been applied to new biologics are separately classified as biosimilar products. The fee for manufacturing authorization (MA) is increased from 8.03 million won (approximately $5,782) to 310 million won (approximately $223,246), and the fee for preliminary safety/efficacy review from 3.01 million won (approximately $2,167) to 155 million won (approximately $111,623), to reflect actual circumstances.B. Fee reduction for biosimilar products from small and medium-sized enterprises (newly established Article 2 (4) (c) in the Draft)To reduce the fees for biosimilar products developed by small and medium-sized enterprises in Korea by 50%. C. Fee reduction of the second MA application for biosimilar products by the same applicant (3 and 26 of Annex 1 in the Draft)When the same applicant files the second application for a different dosage or injection dosage form (including vial, ampule, Pen) for the newly established biosimilar product fee, the current fees for new biologics are applied from the second application.  

Download: Korea Republic: Proposed amendment to the “Regulations on Fees for Pharmaceutical Approval, etc.”

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