Looking at the review date for GIFT No. 1 Lunsumio
By Lee, Hye-Kyung | translator Kim, Jung-Ju
23.11.13 06:57:53
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|Interview| Park Jae-Hyeon, Head of Rapid Review Division, Ministry of Food and Drug Safety
Roche's data preparation period was 7 months
The reason it took 11 months to obtain approval
Park Jae-Hyeon, head of the rapid review division of the Ministry of Food and Drug Safety, announced on the 3rd that the actual review period for Roche Korea's Lunsumio Injection, the first GIFT product to receive domestic product approval, took 86 working days. GIFT's goal was to shorten the general review period by at least 25%.
However, if you look at the period from the expedited review designation on November 29th of last year to
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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