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Lunsumio Provides First Test For Korea's Breakthrough Therapy Program

GIFT Designed To Speed Reviews

 
• By Jung Won Shin

South Korea's breakthrough therapy system, Global Innovative Products Fast Track, kicks off with Roche’s follicular lymphoma drug becoming the first to test the new system. Meanwhile, a state-run group is linking with pharma firms to rapidly bring in global new drugs.

innovative drug
GIFT forms Part Of Korea’s Recent Regulatory reforms • Source: Shutterstock

South Korea's regulatory authorities are making diverse efforts to enable the more rapid introduction of novel therapies to the country. as part of a broad goal of improving patients’ access to medical innovation.

As part of this, the Ministry of Food and Drug Safety (MFDS) has now selected Roche Holding AG’s Lunsumio (mosunetuzumab) as the first product to be reviewed under its new Global Innovative Products Fast Track (GIFT) program, introduced

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