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  • Imlunestrant becomes first reviewed after new drug approval
  • by Lee, Hye-Kyung | translator Alice Kang | Feb 6, 2025 05:56am
Eli Lilly¡¯s imlunestrant becomes the first drug to apply for marketing authorization after new drug approval fee hike
Eli Lilly submits application on January 31 after one preliminary consultation with the MFDS
A dedicated team for the drug review will be formed soon... approval is expected within 295 days
The first application for a new drug license has been submitted since the fee for drug approval was raised to KRW 410 million.

According to industry sources on the 6th, the multinational pharmaceutical company Eli Lilly applied for an marketing authorization for its breast cancer drug 'Inrulio (imlunestrant)' to the Ministry of Food and Drug Safety on Jan. 31.

This is the first new drug application filed since the MFDS drastically improved its new drug approval review process and revised the new drug approval review fee.

The MFDS implemented the New Drug Approval Innovation Plan on January 1, 2025, and introduced various improvements to increase the transparency and predictability of the approval process.
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