New drug approval fees to increase next year
By Lee, Hye-Kyung | translator Alice Kang
24.12.23 05:14:12
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MFDS operates a consultative body to discuss the new drug approval review procedure
Agreed to set the fee at KRW 410 million with the industry...applicants request prior consultation
The Ministry of Food and Drug Safety has completed preparations to raise the fee for new drug approvals to KRW 410 million from January 1 next year.
Since mid-October, the agency has formed the ¡®Consultative Body for Discussions on New Drug Approval and Review Procedures' and completed the 'New Drug Approval and Review Business Procedures (Guidelines for Officials)' after 4 meetings.
The MFDS expects the increase in new drug approval fees to be the first step towards improving the system to the level of the U.S. FDA and the European EMA.
¡ã(From the left) Director Sang-Ae Park, Director Young-Joo Kim, Director Chun-Rae Kim,
The MFDS press corp recently met with Director Young-Joo Kim, Head of the Pharmaceutical Approval Management Division at MFDS; Di
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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