Accelerated review may attract first-ever global new drug filings in Korea

Gov’t to start pre-NDA face-to-face meetings in June…Synergy expected with elimination of CCP requirement

Personnel expanded to 207 for parallel review… dramatically shortens initial feedback timeline

Could a paradigm shift be underway in which global pharmaceutical companies submit new drug applications to Korea's Ministry of Food and Drug Safety (MFDS) before filing in the United States or Europe? Expectations are rising as the MFDS launches a major regulatory service reform aimed at shortening review timelines for new drugs and biosimilars to 240 days, potentially positioning Korea as a preferred first-filing market.

The MFDS, led by Commissioner Yu-Kyoung Oh, announced that it has implemented a comprehensive ‘Medical Product Approval and Review Innovation Plan,’ effective June 1, to accelerate patient access to innovative therapies while supporting the global expansion of Korea's biotechnology industry.

A key component of the initiative is a comprehensive regulatory support framework covering the entire development process—from early-stage product preparation through final approval. To support this effort, the MFDS recruited approximately 200 additional reviewers and established dedicated review teams by specialty area. The agency also introduced a ‘simultaneous and parallel review system’ designed to significantly improve efficiency.

Previously, due to limited personnel, the initial request for additional information typically occurred 87 days after submission (60 working days). Under the new system, the first feedback is expected to be provided within 25 days of submission, enabling companies to identify and address deficiencies much earlier in the review process.

MFDS officials expect the new review framework to work in tandem with the recent elimination of the CCP requirement, which had long been viewed as a barrier for imported medicines entering the Korean market.

During a press briefing held on June 2, Young-Joo Kim, Head of the Regulatory Science Policy Promotion Division, said, “With the CCP requirement removed, shortening review timelines for new drugs could become a true paradigm shift. We may soon see global pharmaceutical companies submitting applications simultaneously in the U.S., Europe, and Korea—or even choosing Korea as the first country in the world for regulatory filing. Given that possibility, our review organization feels a significant sense of responsibility and pressure.”

On the 2nd, the Ministry of Food and Drug Safety held a briefing with journalists regarding innovation plans for medical product approval and review. (From the left) Young-joo Kim (Head, Regulatory Science Policy Promotion Team), Seung-ryeol Ryu (Director, Advanced Medical Device Division), Kyung-seung Shin (Director, Medical Device Approval Division), Hyun-jung Park (Director, Biopharmaceutical Approval Division), Nam-soo Kim (Director-General, Pharmaceutical Approval Management Division), So-hee Kim (Director, Cardiovascular and Neurology Products Division), Ho-Jung Kim (Director, Recombinant Protein Products Division), Yong-seok Koh (Director, Advanced Drug Quality Division II)

Efforts to improve communication and reduce trial-and-error throughout the review process will also be significantly strengthened. A pre-submission checklist outlining key requirements prior to filing will be provided, while the existing consultation process, which was previously limited to a single meeting, will be formalized into Pre-NDA Meetings, guaranteeing at least two opportunities for discussion before submission.

At the briefing, Nam-Soo Kim, Director-General of the Pharmaceutical Approval Management Division, explained, “The checklist will be particularly valuable for venture companies and small-to-medium-sized pharmaceutical firms that often have limited regulatory resources. Even before the official implementation date, companies with products that are sufficiently prepared and request a Pre-NDA Meeting will receive support with the goal of completing the review within 240 days

However, challenges do remain. The expertise of the massively increased personnel needs to be elevated in a short period. Regarding this, Kyung-seung Shin, Director of the Medical Device Division, stated, "It is a fact that it is difficult to immediately deploy new personnel to review new drugs. As we have selected highly experienced reviewers with extensive backgrounds in pharmaceutical companies, we will quickly deploy them to the field through thorough training and internal mentoring to fill the gap."

The pharmaceutical industry and patient groups also seem to actively welcome this improvement in the system. Yeon-hong Noh, Chairman of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, said, "This plan is an innovation that fundamentally changes the structure of the approval and review system beyond a simple race for speed. The industry will also cooperate so that the system can settle in the field by increasing the completeness of application materials." Ki-jong Ahn, representative of the Korea Alliance of Patient Organizations, also said, "I hope that an environment will be created where patients in urgent need of treatment can return to their daily lives as soon as possible."

The MFDS began accepting applications for Pre-NDA Meetings for new drugs, biosimilars, and novel medical devices on June 1. The full 240-day review timeline will officially apply to applications submitted on or after October 1.