Lunsumio, Roche Korea’s lymphoma treatment, has become the first drug designated as the subject of the government’s Global Innovative products on Fast Track (GIFT).
The Ministry of Food and Drug Safety said Tuesday that it had picked Lunsumio Inj. as the first product of the government’s GIGT system it had operated since September to help develop innovative medical products by domestic drugmakers.
GIFT is a program that supports innovative global medical products from the beginning of (clinical) development to their quick commercialization.
More specifically, GIFT’s targets include drugs that treat severe or rare diseases that threaten life; those which treat diseases that had no previous treatments or significantly improved efficacy compared to existing therapies; those which aim to prevent or treat infectious diseases feared to cause serious harm to public health, such as the pandemic or bioterrorism diseases.
Also included in these categories are new drugs developed by innovative pharmaceutical companies designated and announced by the Ministry of Health and Welfare and “fusion products” that combine medicinal products and medical devices subject to fast-track review.
Lunsumio, under development as a treatment for recurrent and refractory follicular lymphoma, was designated as a drug with no existing competitors or needed for an urgent introduction to expand patients’ treatment options.
Suppose a drug is designated as subject to GIFT. In that case, it receives various supports, including preparing application documents, rolling review that examines prepared documents first, close communication between reviewers and developers through product presentations, and receiving regulation-related experts’ consulting services.
Above all, the system’s biggest advantage is shortening the review to 75 percent of the general review. For example, it takes 120 days to review ordinary new drugs, but the period shortens to 90 days for GIFT items.
Meanwhile, the food and drug safety ministry opened a GIFT information page on its main website to ensure the transparency of GIFT designation and help drugmakers confirm related information in one place.