Daewoong Pharmaceutical shared the success story of Enblo Tab, a new type 2 diabetes drug that was approved through an expedited review by the Ministry of Food and Drug Safety.
On the 26th, the Ministry of Food and Drug Safety held a meeting at the Korea Pharmaceutical and Bio Association to support the development of domestic innovative products using the Global Innovative Products on Fast Track (GIFT).
The event was held for four newly designated innovative pharmaceutical companies this year, △Bridge Biotherapeutics △GI Innovation △Phambio Korea △Qurient.
Choi Jong-won, head of development headquarters at Daewoong Pharmaceutical, shared the case of commercialization of Enblo Tab.
Director Choi Jong-won said, “After Enblo Tablet was designated as the No. 1 target for rapid review by the Ministry of Food and Drug Safety, we were able to frequently communicate with reviewers and solve questions immediately through briefing sessions and technical consultations.” might be prepared quickly,” he said.
He added, “The approval period was shortened by two months than expected because the data might be reviewed at any time through the ad-hoc accompanying review system. .
According to team leader Choi, the company actually made early exports to Brazil, Mexico, and Saudi Arabia.
“We are also looking forward to the support of the Ministry of Food and Drug Safety’s Global Food and Drug Policy Promotion Team for overseas exports,” he said. We hope to be able to quickly advance overseas,” he said.
In addition to the success stories of the GIFT system, the support system was also introduced. Currently, through the GIFT system, the Ministry of Food and Drug Safety is supporting △reduction of examination period by at least 25% (e.g., 120 working days → 90 working days) △preliminary review operation from prepared data △internationally harmonized examination standards such as ICH without time lag with overseas countries. appear.
Kim Hee-seong, head of the Rapid Review Division at the Korea Food and Drug Safety Evaluation Institute, said, “We will use this meeting to actively accept the opinions of pharmaceutical companies that need support from the Ministry of Food and Drug Safety for the rapid commercialization of innovative drugs in Korea, and to support the rapid market launch and export of innovative products. We will prepare a strategic support plan for the Ministry of Food and Drug Safety.”
