[Contribution] On MFDS¡¯s new drug approval fee hike
By Whang, byung-woo | translator Alice Kang
24.11.21 05:29:00
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Kyung-won Seo, Chair Professor, Department of Food& Medical products Regulatory Policy, Dongguk University
¡ã Kyung-won Seo, Chair Professor, Department of Food& Medical products Regulatory Policy, Dongguk University
The Ministry of Food and Drug Safety recently announced a significant rise in its new drug approval fee to KRW 410 million. In Korea, the new drug approval fee had remained very low at KRW 8.83 million for decades, compared to the US FDA's KRW 5.3 billion, the European EMA's KRW 490 million, and the Japanese PMDA's KRW 430 million. The fee hike had been long desired by the industry and the MFDS alike, and the MFDS had worked hard to raise the fee. So the significant increase in the new drug review fee means that the value of the new drug review work being carried out by the authorities has been properly recognized, which the MFDS and the MFDS members in charge of new drug approvals should be prou
Whang, byung-woo(dailypharm@dailypharm.com)
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