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Description
of content: 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.
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