MFDS 'Review time shortened after the GIFT introduction'

115 days→63 days

The number of approved cases for innovative new drugs increased by 3.1-fold compared to 2022.

Following the introduction of the Global Innovative products on Fast Track (GIFT) for global innovative products by the Ministry of Food and Drug Safety (MFDS) last year, the time it takes to review pharmaceuticals for severe disease has shortened significantly from the average of 115 days to 62.9 days.

 

Furthermore, the number of approved cases for innovative new drugs increased by 3.1-fold, from 8 to 25, compared to 2022.

 

According to the 'GIFT Monitoring and Plans' unveiled by the MFDS on April 22, the number of cases designated as GIFT increased from 6 cases in 2022 to 16 cases in 2024.

 

The number of approved innovative new drugs also surged.

 

(left) Number of cases designated as expedited review (right) Number of approved innovative news drugs

Notably, proactively running the system has enabled short review time, which falls within 75% of the regulatory review period (within 120 days).

 

The review period reportedly takes 62.9 days.

 

During the regulatory review period, the time it takes to submit document supplementation is not included.

 

An expedited review also excludes the document supplementation period.

 

The MFDS has been operating the expedited review system since August 2020.

 

It has introduced the GIFT for severe disease in 2022.

 

To date, 65 cases have been designated for expedited review system, with 29 cancer drugs and 21 COVID-19 vaccines ranked by highest.

 

In addition, the MFDS has expanded GIFT program criteria to include advanced biopharmaceuticals.

 

For new drugs developed by innovative pharmaceutical companies, the MFDS supports early entries to the GIFT program.

 

Notably, as the Health Insurance Review and Assessment Service (HIRA) revised the 'Specific evaluation criteria of new drugs and medicines in consideration for negotiation,' GIFT-designated new drugs are now acknowledged for 'innovativeness of new drugs' during the ICER value evaluation during the reimbursement evaluation.

 

Furthermore, the 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' aimed at the swift supply of severe rare diseases treatments, also considers GIFT-designated products for their program.

 

Recordati Korea's Qarziba, the 13th GIFT-designated drug for rare cancer in children, took 89 days until marketing authorization review, and it was approved for reimbursement listing six months after approval.

 

This year's '2nd Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations' includes the 24th GIFT drug 'Winrevair,' the 30th GIFT drug 'Fintepla,' and the 33rd GIFT drug 'Rimqarto.' The MFDS stated, "In March, the MOHW revised the pharmaceutical evaluation criteria and newly established drug pricing evaluation for GIFT-designated new drugs developed by innovative pharmaceutical companies," and added, "Criteria for evaluating cost-effectiveness are newly established, such as providing benefits for new drugs when their clinical effectiveness is comparably improved than a substitute drug."