O Yu-kyung, Director of MFDS, "Efforts to Shorten DTx Usage Period... Leading Warm Regulatory Innovation"

O Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, is explaining the direction of regulatory innovation promotion at a press briefing on the 23rd.
[Photo by Ministry of Food and Drug Safety]

[Asia Economy Reporter Lee Gwan-ju] The Ministry of Food and Drug Safety (MFDS) recently approved the country's first digital therapeutic device (DTx, digital therapeutics), and O Yu-kyung, head of the MFDS, anticipated that related procedures for its use in medical settings would also proceed swiftly.

At a press conference on the 23rd, Director O stated, "The current government has a great interest in new DTx, and we are paying overall attention to shortening the period until the first approved product is used by patients." She added, "Under the policy of enabling patients to use good medical products quickly, I believe the procedural principles will be followed accordingly."

The MFDS opened the DTx era by approving AimMed's insomnia DTx 'Somzz' on the 15th. The app provides sleep habit education, real-time feedback, and behavioral interventions over 6 to 9 weeks to improve sleep efficiency and alleviate patients' insomnia. For example, when patients keep a daily sleep diary, the app helps them maintain a fixed sleep schedule and advises minimizing naps, thereby correcting lifestyle habits to improve insomnia symptoms.

The approval was backed by the MFDS's world-class regulatory policies. The 'DTx Approval and Review Guidelines,' the first of their kind globally, have been referenced by countries worldwide, establishing Korea as a regulatory leader. Based on this experience, the MFDS plans to focus on regulatory innovation this year. Director O conveyed the goal, saying, "This year, we will strengthen public confidence through 'safety innovation' and solidify our foundation through 'regulatory innovation.'"

Overview of the Ministry of Food and Drug Safety's 'Bridge Project'. [Photo by Ministry of Food and Drug Safety]

To this end, following the announcement of 100 major regulatory innovations last year, Director O emphasized the ambition to grow into a regulatory agency with 'global leadership.' Specifically, she introduced the 'GPS' policy aimed at elevating Korea's standards to global standards. GPS stands for Global leadership (G), Partner (P), and Supporter (S). The goal is to have Korea's guidelines recognized by international regulatory agency consortia and to support Korean companies' global expansion through collaboration with agencies worldwide.

As part of this, she also presented the 'BRIDGE Project' to accelerate the launch of innovative products. This initiative aims to build a bridge enabling rapid progress from research planning to clinical trials, productization, and market entry for new drug candidates developed by pharmaceutical companies. Director O explained, "The MFDS aims to create a 'bridge' where industry and regulation help, collaborate, push, and pull each other."

This year, efforts will also be intensified in managing narcotics, a growing social issue. The recently enhanced 'Integrated Narcotics Management System,' which played a significant role in curbing propofol abuse, will be further advanced while reducing inconvenience for patients who genuinely need narcotic prescriptions. Director O stated, "The Integrated Narcotics Management System cracks down when usage exceeds safety standards by a large margin," adding, "We will carefully monitor the system and also inspect manufacturing companies."

This content was produced with the assistance of AI translation services.