Oh Yu-kyung: "Digital Medical Regulations, Our Standards Will Become Global Standards... AI Symposium with FDA Next Year"

Meeting with Oh Yu-kyung, Director of the Ministry of Food and Drug Safety
International cooperation efforts including the establishment of 'Aplus' and collaboration with the FDA
"FDA proposed to lead AI cooperation first"
Emphasis on 'proactive investigation' amid domestic pharmaceutical quality controversies

The Ministry of Food and Drug Safety (MFDS) reaffirmed its commitment to becoming a global standard-bearer for digital medical products such as artificial intelligence (AI) medical devices and digital therapeutics (DTx). The plan is to lead global food and drug regulations through comprehensive international cooperation, including not only digital medicine but also achievements such as being the first in the world to be listed on the World Health Organization (WHO) Good Regulatory Practice List (WLA) for vaccines and pharmaceuticals, and leading the establishment of the world's first regulatory agency consortium in the food sector, the Asia-Pacific Food Regulatory Authorities Summit (APFRAS).

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, is speaking at a press conference for reporters covering the Ministry held on the afternoon of the 28th in Jongno-gu, Seoul.
[Photo by Ministry of Food and Drug Safety]

On the afternoon of the 28th, at a press briefing held in Jongno-gu, Seoul, Commissioner Oh expressed his determination to lead global regulations through continuous regulatory innovation and development, stating, "Let our standards become the global standards."

This confidence was also evident when Commissioner Oh cited four major achievement areas this year: ▲digital innovation ▲warm public welfare ▲regulatory innovation ▲international cooperation, highlighting significant accomplishments particularly in digital innovation and international cooperation.

First, in the field of digital innovation, achievements such as 'Electronic Review 24 (safe-i 24)' and 'approval of digital therapeutics (DTx)' were presented. Commissioner Oh emphasized, "Through Electronic Review 24, the (food) import declaration inspection process has been shortened to within five minutes," and explained, "Riding the momentum of the first DTx approval, we proposed the Digital Medical Devices Act, which passed the Health and Welfare Committee last week." Given the surge of various digital medical products such as DTx and AI medical devices, the MFDS plans to prepare legislation to support these within the 21st National Assembly session.

'AI International Regulation Symposium (AIRIS 2024)' logo [Photo by Ministry of Food and Drug Safety]

Commissioner Oh also emphasized several achievements in international cooperation. The keywords here were APFRAS, established in May, and the 'AI Regulatory International Symposium (AIRIS 2024)' scheduled to be held in Seoul in February next year in cooperation with the U.S. Food and Drug Administration (FDA).

APFRAS is the world's first consortium of food-related regulatory agencies, aiming to build an international regulatory cooperation system among Asia-Pacific countries. Commissioner Oh stated, "Our Republic of Korea, as the chair country, will work hard toward regulatory harmonization in the Asia-Pacific region." Going forward, the MFDS will lead the consortium as chair for three years and will play a leading role in cooperation through the permanent secretariat established within the MFDS.

AIRIS is the result of ongoing cooperation with the FDA since early this year, including Commissioner Oh's visits to the U.S. in March and April to meet with FDA Commissioner Robert Califf. He explained the significance, saying, "Including the era of the Korea Food and Drug Administration, this is the first time an MFDS commissioner and FDA commissioner have met face-to-face for consultation," and added, "While discussing what more could be done, we decided to hold a major symposium on AI regulation in February next year. The MFDS and FDA are consulting monthly to prepare AIRIS."

AIRIS is scheduled to be held at the Shilla Hotel in Jung-gu, Seoul, in February next year, and participation has been requested from more than 30 regulatory agencies worldwide. Commissioner Oh emphasized, "Since all regulatory agencies will come to Korea, the international network will expand, and we will issue an outcome statement summarizing the meeting content."

Regarding this cooperation, Commissioner Oh repeatedly emphasized that it is an achievement recognizing Korea's advanced regulations overseas. For example, the MFDS was recently listed on the WHO Good Regulatory Practice List (WLA). The WLA is a list of agencies evaluated to have met a certain level of pharmaceutical and vaccine regulatory systems and operational capabilities. It was established to facilitate pharmaceutical procurement by UN agencies such as UNICEF. Notably, this WLA listing was the world's first alongside Singapore's Health Sciences Authority (HSA) and Switzerland's Swissmedic.

Regarding AI, he said, "When discussing which agenda to cooperate on with the FDA, the U.S. suggested moving quickly on AI regulation," and emphasized, "Korea, which is ahead, believes that by working together, we can advance rapidly." He explained the significance, saying, "If a common guideline is created through this process, I believe our standards can become global standards," and "Once our digital medical products are approved domestically, they can enter the global market."

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, is speaking at a press conference for reporters covering the Ministry held on the afternoon of the 28th in Jongno-gu, Seoul.
[Photo by Ministry of Food and Drug Safety]

Commissioner Oh also mentioned public welfare and regulatory innovation, which he identified as other core areas. In the public welfare sector, he said, "There are many harmful substances in cigarettes, but they are not well indicated on cigarette packs," and expressed pleasure that the Tobacco Harmfulness Management Act, which allows harmful substances to be listed, passed after 10 years. Regarding drugs, which have recently become a social issue, he said, "There is a blind spot in drug rehabilitation," and announced plans to open 14 addiction rehabilitation centers next year, aiming to establish centers monthly across 17 cities and provinces nationwide.

In the field of regulatory innovation, 'Regulatory Science (RA)' was emphasized as a key keyword. Commissioner Oh explained, "RA is a new field with few experts," and said, "The Regulatory Science Innovation Act was passed with the goal of nurturing talent in regulatory science and supporting the rapid commercialization of new technologies, leading to the establishment of the Regulatory Science Innovation Promotion Team."

Oh Young-jin, MFDS Global Export Strategy Officer, also mentioned the case where 2-chloroethanol was detected in ramen, leading the European Union (EU) to strengthen regulations. He said, "The MFDS strengthened safety management and scientifically proved non-detection, dispatched a delegation to the EU to persuade them, and the regulation was lifted abruptly in June," adding, "This is an unusual case of resolving regulation in a short period, resulting in a 23 billion KRW export increase from the company's perspective," citing it as an example of regulatory innovation.

Regarding recent controversies over pharmaceutical quality, such as Daewon Pharmaceutical's 'Potagel' being recalled due to exceeding microbial limits, Commissioner Oh emphasized proactive preemptive measures. He said, "In the case of Potagel, we found many problems with gel-type pharmaceuticals during investigations," and added, "We intend to conduct preemptive investigations on formulations that may have safety blind spots or require caution, serving to raise awareness in the industry."

Following this, Kang Seok-yeon, Director of the Pharmaceutical Safety Bureau at the MFDS, said, "We are making efforts to ensure excellent products are supplied through various education, guidance, and supervision related to Good Manufacturing Practice (GMP)," and added, "With the upgraded GMP, 'Quality by Design (QbD),' we aim to fundamentally improve mistakes related to GMP."

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