23 items have been designated as Fast Tracks in 2yrs

Half of the drugs are anti-malignant

The first designation in Korea is Selumetinib and DWP16001

Goal of completion of examination within 75% of general examination period.

 

Over the past two years, 23 items of medicine have been designated as Fast track.

 

Specifically, it appeared as 4 items in 2020, 11 items in 2021, and 8 items until July 2022, and the reason for the increase in Fast track designated drugs last year compared to the previous year is interpreted as the impact of the COVID-19 vaccine.

 

The MFDS (Director Oh Yoo-kyung) published a "Fast Track Drug Review Report" on the 13th by launching the "Global Innovative Products on Fast Track (GIFT) Program" to support the development of innovative medical products in Korea.

 

Since August 31, 2020, the Ministry of Food and Drug Safety has established a Fast Track department and has designated and reviewed Fast Track items for innovative products such as life-threatening diseases or treatments for rare and incurable diseases.

 

The items designated as Fast Track for the first time in Korea were AstraZeneca's Selumetinib and Daewoong Pharmaceutical's DWP16001, an innovative pharmaceutical development new drug, applied simultaneously on October 23, 2020.

 

The application for Fast Track designation requires active ingredients, mechanism of action, manufacturing method, preliminary clinical trial data to confirm clinical significance in the disease, and target indications, and the application for designation will be reviewed within 30 days.

 

Over the past two years, a total of 17 items have been approved after the Fast Track designation, including 5 chemicals, 1 biopharmaceutical, 10 COVID-19 vaccines, and 1 biopharmaceutical, with the goal of completing the screening within 75% of the screening period.

 

From August 31, 2020 to July 31, this year, a total of 25 applications for the designation of medical products Fast Track were designated, of which 23 were designated.

 

One of the items applied for designation was not designated due to insufficient data to prove the effectiveness improvement compared to existing treatments, and one was voluntarily withdrawn.

 

Among the Fast Track designated items, 12 treatments for life-threatening or serious diseases, 7 drugs for preventing or treating infectious diseases for public health hazards, and 4 new drugs for developing innovative pharmaceutical companies.

 

By drug group, anti-malignant tumors were 56.5% (13 items), COVID-19 treatments and vaccines 30.4% (7 items), chemotherapy drugs 4.3% (1 item), circulatory mechanical drugs 4.3% (1 item), and diabetes solvents 4.3% (1 item).

 

Of the 17 Fast Track item permits, COVID-19 vaccines accounted for a high proportion of 10 items and 5 items of anti-malignant tumor drugs.

 

Eight of the designated items are currently undergoing screening, and one item has not applied for permission.

 

The average number of fast track days for the COVID-19 vaccine was 26 working days, and the average number of items excluding the vaccine was 51 working days.

 

22 preliminary reviews have been conducted so far to shorten the period of approval before applying for item permits.

 

In the case of occasional screening using the preliminary review system when performing Fast Track, COVID-19 vaccines such as AstraZeneca, Pfizer, and Janssen applied for the screening.

 

The Ministry of Food and Drug Safety is planning to launch a GIFT program based on its Fast Track experience over the past two years.

 

The GIFT program is a program that supports global innovative medical products from the beginning of development (clinical) to quickly commercialize them, and pharmaceutical companies review designations when applying for Fast Track targets and, if necessary, decide on GIFT targets after consulting the Fast Track expert council.

 

The GIFTprogram targets will receive various support such as applying rolling reviews that examine the prepared data first, close communication between reviewers and developers, regulatory consulting, and clinical results for products with excellent innovation (improvement of safety and effectiveness), submission after market, and preemptive application of global screening standards such as ICH.