Authorization rate for No.16 is still 0%

The Ministry of Food and Drug Safety recently designated 'BI 1015550' as a substance, starting with 'Run Sumio' in November last year

New 'GIFT' system for rapid screening of global innovative products in September last year

While the Ministry of Food and Drug Safety recently completed the designation of 'Global Innovative Product Rapid Review (GIFT)' No.

 

16, there are still no items that have been approved using this system.

 

The Ministry of Food and Drug Safety established the Global Innovative Products on Fast Track in September last year.

 

It also contains innovative, gifted medicines that can pioneer new areas of treatment.

 

The most recently designated GIFT item is the 'BI 1015550' substance, a treatment for idiopathic pulmonary fibrosis.

 

The product name has not been confirmed.

 

The drug has been designated as a GIFT for improved effectiveness, and is currently being approved by the U.S.

 

FDA in BTD process.

 

In Korea, it was also designated as a gift item on September 12th.

 

The items subject to GIFT are limited to ▲medicines for the purpose of treating serious diseases such as life-threatening cancers or rare diseases ▲medicines for the prevention or treatment of infectious diseases that may cause serious harm to public health, such as the spread of bioterrorism infections or infectious diseases ▲new drugs developed by innovative pharmaceutical companies designated by the Ministry of Welfare ▲combination of drugs and medical devices .

 

There are no existing treatments or have been clinically meaningful improvements in effectiveness than existing treatments.

 

If designated as a target for Hinban GITF, it will be received at least 25% reduction in the review period (e.g., 120 working days → 90 working days), application of rolling review from the prepared materials first, close communication between reviewers and developers such as item briefing sessions and supplementary briefing sessions, and regulatory-related professional consulting.

 

The GIFT system is a branded rapid examination program that has been operated since the establishment of the rapid examination department, and was prepared to activate the rapid examination conducted for two years and to strengthen the rapid commercialization of innovative products.

 

Since the rapid examination was established in August 2020 and the rapid examination was started, a total of 33 items were designated for rapid examination until July, of which 28 items, or 85%, were approved.

 

The gift-designated items are aiming to shorten to 75% of the 120 working days, which is the general screening period, but there is still no news of the approval of Roche Korea’s product, which was designated in November last year.

 

An official from the Ministry of Food and Drug Safety said, "There are no GITF approved items as it takes time for the company to prepare supplementary materials after the actual first screening, but it is expected that the GIFT designated items will be linked to the permission in the second half of this year."