AZ Capivasertib, designated GIFT No. 8

The GIFT designation rate is 61%

GIFT system was established in September last year

Performance of new drugs developed in Korea such as Bronpass, Skycovione Multi Inj., and Envlo

On the 4th, the Ministry of Food and Drug Safety designated AstraZeneca Korea's breast cancer treatment Capivasertib as the 8th "Global Innovation Product Rapid Review (GIFT)." Starting with Lunsumio, a lymphoma treatment in Roche Korea, which was designated as GIFT No.

 

1 in November last year, it has been designated up to No.

 

8 recently, but none of the items have been officially approved yet.

 

In this regard, Park Jae-hyun, head of the rapid review division of the Ministry of Food and Drug Safety, said in a briefing for reporters on the 4th, "Even if it is designated as GIFT, it may not apply for permission for each item." However, since a total of eight items have been designated starting with Lunsumio, the GIFT No.

 

1, Park explained that GIFT designated items are expected to be linked to permits in the second half of this year.

 

Since the establishment of the GIFT system, a total of 13 items have been applied for rapid review, and eight of them have been designated as targets.

 

In the end, it means that the designation rate is not as high as 61%.

 

This is because GITF items are limited to ▲ drugs aimed at treating serious or rare diseases such as life-threatening cancer, ▲ drugs aimed at preventing or treating infectious diseases such as bioterrorism or infectious diseases, ▲ new drugs developed by innovative pharmaceutical companies designated by the Ministry of Welfare, ▲ rapid screening, and medical devices or ▲ if there is no existing treatment or if there is a clinically significant improvement in effectiveness compared to the existing treatment Park said, "When I meet with the pharmaceutical industry, I receive many suggestions to expand the scope of rapid review." "Among them, we are sometimes asked to include improved new drugs in the rapid review, and although it is difficult due to a lack of manpower, we plan to review them in the mid- to long-term," he said.

 

The hurdles are high, but if designated as GITF targets, ▲ the screening period will be reduced by at least 25% (e.g., 120 working days→90 working days), ▲ close communication between reviewers and developers, such as item briefings and supplementary briefings, or ▲ regulatory-related consulting.

 

The GIFT system is a branding of the rapid review program that has been operated since the establishment of the rapid review and has been in full force since September last year to revitalize the two-year rapid review and strengthen support for rapid commercialization of innovative products.

 

Starting with frequent screening of COVID-19 vaccines and treatments, the rapid screening of drugs is Daewoong Pharmaceutical's Envlo 0.3mg and AstraZeneca's Koselugo 25mg.

 

With the introduction of rapid screening in Korea, items such as the COVID-19 treatment Regkirona, COVID-19 AstraZeneca vaccine, Pfizer vaccine, Janssen vaccine, Moderna vaccine, etc.

 

were approved in 2021.

 

Manager Park explained, "Since the rapid examination department was established in August 2020 and the rapid examination began, a total of 33 items have been designated for rapid examination, and 28 items have been approved, and about 85% have been approved." "Over the past three years, the average number of days required for rapid review of designated items has been 65 working days, and in the case of the COVID-19 vaccine, 28.7 working days, less than 30 days on average," he explained.

 

Among them, Daewoong Pharmaceutical's Envlo reduced the screening period by 59% compared to 120 working days, and reduced the screening period by more than 100 days compared to the average new drug screening period from 353 days, including the data supplement period.

 

Manager Park said, "GIFT designated items aim to be reduced to 75% of the general screening period, and it is difficult to calculate and answer the entire screening date because there are no items that have been approved yet." "For reference, you can refer to the overall average screening date of items subject to rapid screening over the past three years by the rapid screening department," he said.

 

Regarding the criticism that the GIFT system seems to have focused only on foreign pharmaceutical companies, Park explained, "When the Pharmaceutical Affairs Act is revised for rapid review, the law has been revised to support the development of the domestic pharmaceutical industry." "Since February, we have been operating GIFT Kiwoom, a 1:1 consultative body with developers, focusing on domestic innovative pharmaceutical companies to support commercialization such as item permits," he said.

 

Currently, there are 48 innovative pharmaceutical companies certified by the Ministry of Health and Welfare, of which 46 are domestic pharmaceutical companies, so it is expected to help designate new drugs developed by domestic pharmaceutical companies as GIFT.