515 days required from GIFT designation to approval

Analysis of 10 products approved in 2026… time required to prepare and supplement global data

New drugs that received marketing authorization this year (2026) through the Ministry of Food and Drug Safety's 'Global Innovative products on Fast Track (GIFT)' program took an average of 515 days from the designation date to final approval. Although the MFDS has significantly shortened its actual review time, a significant amount of time was taken by the pharmaceutical companies to prepare and supplement extensive global approval data.

Dailypharm’s analysis of 10 products (GIFT Nos. 50–59) that obtained marketing approval through the MFDS' GIFT program in 2026 found that the average elapsed time from GIFT designation to final approval was 515.5 calendar days.

The fastest approval was achieved by ‘Wainua Autoinjector (eplontersen),’ developed by AstraZeneca Korea for transthyretin-mediated amyloidosis. The product received marketing approval in July 2026, just 305 days after receiving GIFT designation in September 2025.

In contrast, Verto Korea’s orphan drug ‘Joenja Tab’ recorded the longest timeline at 801 days, from its GIFT designation in April 2024 to final approval. Other products that took more than a year and a half included ‘Lamzede Inj’ from Kwangdong Pharm (767 days) and ‘Rimqarto Inj’ from Curocell (631 days)l, Korea's domestically developed CAR-T therapy.

Time from GIFT designation to approval for key products approved in 2026

The average timeline of approximately 17 months (515 days) is largely affected by the period required for companies to prepare and submit supplemental data. In other words, the entire period between GIFT designation and final approval should not be interpreted as a delay in the MFDS review process. Nevertheless, further efforts to minimize the need for additional submissions will be necessary to ensure that patients gain faster access to innovative medicines.

Through the GIFT program, the MFDS aimed to shorten the statutory review period by 25%, completing reviews within 90 working days instead of the standard 120 working days. In practice, the agency's actual review time has been shortened, averaging around 60 to 70 days.

The challenge arises when the MFDS requests additional information during the review process, at which point the statutory review clock stops. Industry sources noted that because many GIFT-designated products are innovative medicines from global pharmaceutical companies or advanced biopharmaceuticals, it often takes several months, or even more than a year, to coordinate GMP inspections at overseas manufacturing sites, conduct additional analyses of multinational clinical data, complete quality verification, and prepare supplementary materials in consultation with global headquarters.

Building on the expertise gained through the GIFT program's ‘expedited review and rolling review’ system, the MFDS is also accelerating efforts to shorten approval timelines for all new drugs.

After reducing the average review period for new drug approvals from approximately 420 days to 295 days, the agency introduced a new 240-day review framework in 2026, which is one of the fastest in the world. To support this initiative, it significantly expanded its review workforce and replaced the previous sequential review structure for nonclinical, clinical, and quality assessments with a parallel review system conducted simultaneously across departments.

The MFDS has also institutionalized at least two ‘pre-submission face-to-face meetings ‘ before companies file marketing authorization applications to reduce approval delays caused by requests for additional information. By providing guidance and checklists in advance to improve documentation quality, the agency aims to minimize clock-stops during the review process.

An MFDS official said, "We are fundamentally transforming the drug review system to create an environment in which patients can gain access to new medicines faster than anywhere else in the world. We will continue strengthening the predictability and transparency of the GIFT program while working closely with industry so that companies can bring innovative medicines to market without the burden of extensive supplementary submissions."