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  • Roche Lunsumio, domestic approval imminent
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Oct 31, 2023 05:35am
Ministry of Food and Drug Safety completes safety and efficacy review
Roche Korea's 'Lunsumio', which was designated as the first product of the Ministry of Food and Drug Safety's GIFT program in November last year, is expected to receive domestic product approval soon
According to the pharmaceutical industry on the 30th, the Ministry of Food and Drug Safety completed the safety and effectiveness review of Lunsumio. Completing this review means that the product approval process will soon begin. Lunsumio was designated as a GIFT item as the urgency of its introduction to expand patient treatment opportunities was recognized as the target disease is relapsed or refractory follicular lymphoma and is a drug for which there is no existing treatment.

When designated as a GITF target, the review period is shortened by at least 25% (e.g. 120 ¡æ 90 working days), the rolling review is applied to review prepared materials first, close communication between reviewers and developers through
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