The Ministry of Food and Drug Safety (MFDS) decided to significantly raise its new drug approval fee to expand its capability for the prompt review of newly developed drugs.

The fee for new drug approval, which was previously KRW 8.83 million, was increased 48 times to KRW 410 million based on the benefit principle.

Despite the dramatic increase, there has been little backlash as Korea’s drug approval fee has been relatively low compared to overseas.

The MFDS aims to raise the new drug approval fee from next year after a 60-day administrative notice period.

As the pharmaceutical industry has been actively supporting the realization of the fee, there have b