O Yu-kyung, Head of MFDS, Says "We Will Consider Smart Regulations That Support Industrial Growth"

New Year's Address 2024

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, expressed her New Year's resolution, stating, "We will consider smart regulations that firmly ensure public safety while supporting industrial growth."

Oh Yu-kyung, Director of the Ministry of Food and Drug Safety
[Photo by Yonhap News]

In her New Year's address on the 1st, Commissioner Oh evaluated the past year as "a year of laying the foundation for food and drug safety to stand shoulder to shoulder with global regulatory powers." She explained that while establishing the foundation for regulatory innovation through legislative improvements such as the full revision of the Food and Drug Regulatory Science Innovation Act and the enactment of the Digital Medical Products Act, the ministry also showcased its regulatory capabilities globally by being listed as an excellent regulatory agency by the World Health Organization (WHO) and leading the establishment of the Asia-Pacific Food Regulatory Agencies Summit (APFRAS).

However, Commissioner Oh noted, "The challenges before us this year are by no means easy," evaluating that "the food and drug industry is evolving into a new growth area where remarkable technological advancements such as artificial intelligence (AI) and food tech are being realized, while factors threatening public safety, such as the surge in drug offenders, still persist."

In response, Commissioner Oh emphasized that "innovative approaches are required to read the times and navigate social demands," presenting three policy priorities under the vision of 'Turning crises into new opportunities, environmental changes as the starting point of challenges': ▲ food and drug safety ▲ public demands and expectations ▲ safety nets and global expansion.

First, in food and drug safety, she pledged to strengthen "science-based regulation and expertise." Commissioner Oh stated, "We will systematically organize the infrastructure of regulatory science professionals in both the private and public sectors and establish a regulatory support system for various new technologies to create a science-based regulatory ecosystem." She added, "By promoting digital innovation in administration, such as building a hazardous imported food screening system using AI technology and expanding electronic review for all imported foods, we will make safety management more thorough while making it convenient for the public."

Next, listening to public demands, she emphasized creating a 'field where expectations become reality.' This includes building an information network that allows real-time access to various information and fully operating the medical device adverse event compensation mutual aid system to address everyday inconveniences of the public. She also said, "We will support innovations demanded by the field so that regulations become a competitive advantage for companies," and announced plans to promote initiatives such as "introducing a cosmetic safety evaluation system and establishing a foundation for fostering contract development and manufacturing organizations for biopharmaceuticals."

Finally, she highlighted safety nets based on cooperation and global expansion. The plan includes advancing an AI-based automatic analysis system for drug abuse cases to swiftly block illegal distribution of medical narcotics, expanding the ‘judicial-treatment-rehabilitation linkage model’ by installing addiction rehabilitation centers nationwide to strengthen a cross-ministerial safety net for drug prevention and addict rehabilitation. Globally, she stated, "We will expand the Global Partnership Strategy (GPS) for export support, hold Korea-US AI workshops, and pursue membership in the Medical Device Single Audit Program (MDSAP) to strive for a leap into the global regulatory leadership group." She added, "We will also broaden inter-country cooperation such as mutual recognition of manufacturing and quality management and strategically support our companies’ overseas expansion."

Commissioner Oh concluded, "The year 2024 will be a year when food and drug regulations become a force that creates social value," and reiterated, "We will continue to consider smart regulations that firmly ensure public safety while supporting industrial growth."