Daewoong Pharmaceutical announced that Enblo Tab. was announced as a successful case of rapid product development at the ‘Innovative Pharmaceutical Company GIFT Rapid Review Support Conference’ co-hosted by the Rapid Review Division of the Food and Drug Safety Evaluation Institute and the Korea Pharmaceutical Bio Association at 3:00 pm on the 26th. .
The meeting was attended by Suh Gyeong-won, head of the Korea Food and Drug Safety Evaluation Institute, Kim Hee-seong, head of the rapid review department, and officials from innovative pharmaceutical companies (including new designation in 2023).
The meeting consisted of ▲introduction of successful commercialization cases through rapid screening ▲introduction of programs such as the GIFT support system ▲discussion on innovative pharmaceutical company support plans.
Development team leader Lee So-yoon of Daewoong Pharmaceutical, who announced a success case of commercialization through rapid examination, developed and reviewed Enblo Tab. Introduced cases of work carried out closely with related authorities, such as the Expedited Review Division.
It was very helpful for Team Leader Lee to undergo pre-evaluation using the frequent accompanying review system and to communicate with the reviewers at any time through item briefings and supplementary briefings, etc., and frequent discussions on submitted data from the submission of supplementary materials until the completion of the review. and data preparation guidance and data reinforcement were conducted in real time as a major factor that significantly reduced the review period.
In particular, in the final stage of review completion, the reviewer personally found and explained related guidelines, and solved the difficulties of preparing data together without weekends. .
The introduction of the ‘Global Innovative Products on Fast Track (GIFT) Support System’, which supports early commercialization of innovative global medical products, was conducted by Kim Hee-seong, Director of Fast Track, Food and Drug Safety Evaluation Institute.
When designated as a GIFT item, various support is provided for rapid commercialization, such as frequent accompanying examinations that review prepared data first, and professional consulting through 1:1 close support between the reviewer and the developer. In particular, new drugs developed by innovative pharmaceutical companies are subject to GIFT designation. included in
Choi Jong-won, head of Daewoong Pharmaceutical’s development headquarters, said, “Enblo Tab. is the No. 1 item subject to rapid review by the Ministry of Food and Drug Safety. After applying for approval, the key points of the GIFT system were applied, so we were quickly reviewed and were able to succeed in development. We were able to advance into overseas markets such as Brazil, Mexico, and Saudi Arabia one step faster. Daewoong Pharmaceutical’s global strategy is expected to gain further momentum,” he said. “We expect many new drugs developed in Korea to succeed in commercialization faster through the support for GIFT, one of the top 100 tasks for regulatory improvement by the Ministry of Food and Drug Safety. “he said.
On the other hand, Daewoong Pharmaceutical’s SGLT2 inhibitor-type diabetes treatment enblot aims to launch in Korea in the first half of this year.
Enblo Tablet, developed for the first time in Korea with domestic technology in the relevant series, has confirmed its excellent blood sugar lowering effect and safety in type 2 diabetes patients through clinical trials.
