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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


"The goal of the GIFT program is to shorten the general review period by 25%. The statutory review period is 120 days for chemical drugs and 115 days for biopharmaceuticals, but GIFT items In the case of, the goal is to complete the review within 90 days.¡±

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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