‘MFDS will review new drugs faster than the US and Europe’

Keynote speech at the KFDC Spring Conference, “shortening review times is meaningful for patients, companies, and the MFDS alike.”

Joon-Soo Shin, Director General of Pharmaceutical Safety Division, delivers a keynote speech at the 2026 Spring Conference of the Korean Society of FDA Regulatory Science on June 5.

“Even if a multinational pharmaceutical company submits applications simultaneously in the United States, Europe, and Korea, Korea could be the first country to grant approval.” The Ministry of Food and Drug Safety (MFDS) has set an ambitious goal of elevating its review capabilities and regulatory systems to a global top-tier level, to ultimately make Korea the first country in the world to approve innovative new drugs.

On June 5, Joon-Soo Shin, Director General of the Pharmaceutical Safety Division at the MFDS, unveiled the agency’s Five-Year Comprehensive Plan for Pharmaceutical Safety Management during a keynote address at the 2026 Spring Conference of the Korean Society of Food, Drug and Cosmetics Regulatory Sciences, held at the Hoam Faculty House Convention Center of Seoul National University under the theme “Interdisciplinary Perspectives and the Immediate Markett Entry System in the AI Era.”

During the speech, Shin repeatedly emphasized that the “240-Day Approval and Review System” would represent a major milestone not only for patients and pharmaceutical companies, but also for the MFDS as the regulatory authority.

Shin said, “Achieving a 240-day review timeline is both highly challenging and highly significant for the MFDS. If a multinational pharmaceutical company were to submit applications simultaneously in the U.S., Europe, and Korea, Korea would be positioned to grant approval sooner than the U.S. (300 days) or Europe (365 days), which poses a significant burden on our part.”

Shin continued, “To achieve this timeline, we must thoroughly prepare our review capabilities and build a system capable of completing the process within 240 days, including all periods required for supplementary submissions. We will ensure smooth implementation through close collaboration with industry, continuous review procedures, and greatly expanded pre-submission consultations.”

To support this initiative, the MFDS implemented detailed operational guidelines on June 1 and has already begun applying them in practice. Rather than simply eliminating procedural steps, the agency introduced a process innovation that converts sequential reviews into parallel and simultaneous reviews. In addition, the dedicated review team was expanded from 15 to 20 personnel. A communication framework has also been established to improve predictability by providing checklists in advance and continuous feedback.

The substantial reduction in review timelines is expected to maximize palpable benefits for both patients and pharmaceutical companies. Shin explained, “By reducing the average review period from 420 days to 240 days, patients with rare and intractable diseases gain 180 days, roughly 6 months,of valuable treatment time.” He added that, from an industry perspective, “In addition to the promotional advantages associated with accelerated approval, faster review timelines will be particularly beneficial for companies that develop biosimilars, as speed is of the essence in securing market competitiveness.”

Addressing concerns raised by some observers regarding potential declines in review quality, Shin firmly rejected the notion. “This initiative does not involve omitting data reviews; rather, it is a procedural improvement. Therefore, this will not compromise review quality. We will allocate the majority of our personnel resources to safety evaluations.”

In fact, the MFDS previously implemented an unprecedented expansion of its review workforce, hiring 195 full-time reviewers with the revenue generated by raising new drug application fees to KRW 410 million 2 years ago. Shin stated, “We were initially concerned about recruiting talent because the positions are based in Osong, but applications exceeded expectations, with competition among highly competent reviewers reaching 12-to-1. We will provide the support necessary for these reviewers to fully demonstrate their capabilities and plan to assign our most highly competent reviewers to handle approximately 80% of new drug evaluations.”