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

Updated on : 21-09-2025

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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