Ministry of Food and Drug Safety Advances to Ensure Food and Drug Safety While Breaking Down Regulations

2023 Major Work Plan Report
Focused on Safety Innovation and Regulatory Innovation Themes

Ensuring Speed through Automation in Various Food, Drug, and Medical Safety Areas
Comprehensive Support for Drug Issues from Prevention to Rehabilitation

Active Support Promotion in Line with Digital Health Transformation

President Yoon Suk-yeol is speaking at the briefing on the work of the Ministry of Health and Welfare, Ministry of Employment and Labor, Ministry of Gender Equality and Family, Ministry of Food and Drug Safety, and Korea Disease Control and Prevention Agency held at the Blue House's Yeongbingwan on the 9th. [Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety (MFDS) has unveiled a vision to further strengthen food and drug safety this year while innovating related regulations to the maximum extent to support industrial development.

On the 9th, the MFDS reported its major work plan for 2023 to the Presidential Office under the vision of "Strengthening the daily lives of the people through safety innovation, solidifying the food and drug industry through regulatory innovation." The MFDS aims to lead international standards with food and drug administrative innovation by pursuing safety innovation and regulatory innovation this year.

In terms of safety innovation, the MFDS has set four key tasks: ▲ innovating a digital-based smart safety system ▲ strengthening the narcotics safety net from prevention, crackdown to rehabilitation ▲ proactive harmful substance risk assessment centered on people ▲ implementing warm safety that embodies social values. For regulatory innovation, the four key tasks are: ▲ innovating with a regulatory system tailored to new technologies ▲ accelerating product launches through regulatory support bridges ▲ promoting field-experienced regulatory innovation 2.0 ▲ facilitating global market entry by overcoming global regulatory barriers.

MFDS Commissioner Oh Yu-kyung stated, "Our society is currently experiencing an increasing desire for healthy living due to demographic changes, and innovative technologies such as artificial intelligence (AI) and digital are spreading across industries." She added, "We will do our best in safety innovation to prepare for new risk factors and regulatory innovation that leads industrial challenges and growth." Furthermore, she said, "Public reassurance will become the MFDS's standard, and our standard will become the world's standard," adding, "We will be the driving force that strengthens the daily lives of the people and solidifies the food and drug industry.

Strengthening Safety through Digital Transformation... Comprehensive Narcotics Lifecycle Management

In food safety, the existing import food inspection, which was manually conducted, will be transformed into a digital automatic inspection system by introducing the 'imported food electronic inspection' system to enhance speed and accuracy. Additionally, by utilizing the Internet of Things (IoT) for process monitoring, smart manufacturing management will be expanded, and an AI-based risk prediction model will be introduced to improve the accuracy of selective inspections of imported foods.

Particularly, for ready-to-eat foods and other home meal replacements, whose consumption has recently increased, a nationwide survey on harmful contaminant levels will be conducted to re-evaluate standards and specifications.

Moving away from the traditional crackdown-centered approach, which has recently become a social issue, the MFDS emphasized establishing a virtuous cycle management system that combines prevention, crackdown, and rehabilitation policies to suppress demand.

In prevention, customized education targeting students and youth will be strengthened. In crackdown, the temporary designation period for narcotics will be shortened to quickly block the influx of new narcotics, and the expansion of prescription statistics information to check overprescription and the phased mandatory implementation of patient medication history inquiries will be promoted.

Especially, rehabilitation will be strengthened to fully support complete social reintegration. The number of addiction rehabilitation centers, currently two, will be increased by one this year, with plans to expand to all 17 cities and provinces in the long term. Customized rehabilitation programs and a Korean-style social rehabilitation model will also be developed.

Regarding side effects of therapeutics that received Emergency Use Authorization (EUA) during the COVID-19 pandemic, national compensation will be implemented. For medical devices that require rare or urgent introduction, the nationwide supply chain will be expanded, and manufacturing and quality control technology development will be conducted to support the localization of essential national medicines.

Comprehensive Regulatory Innovation... Active Support for Digital Transformation and New Bio Technologies

On the regulatory front, the digital transformation, which the MFDS has been actively promoting recently, is expected to gain further momentum. The integrated review system for innovative medical devices, introduced in October last year, will be fully operational this year. This system integrates reviews of innovation, safety, and efficacy of medical devices, significantly shortening the review period to 80 days, and will be announced monthly to increase participation.

Additionally, various digital-specialized systems will be established, including exemption from MFDS approval for exploratory clinical trials, allowing wearable devices to conduct clinical trials outside designated institutions, and improving software business systems. The MFDS plans to enact the 'Digital Medical Products Act' around March to institutionalize these measures.

Institutionalization of diversified bio-technology areas such as microbiomes and exosomes will also be achieved. Definitions and classification criteria for new technology pharmaceuticals will be established, and approval review data requirements and facility standards considering product characteristics will be presented. To support the development of next-generation vaccines, the Vaccine Safety Technology Support Center, scheduled to open in November, will provide dedicated support from cell line distribution to licensing consulting for product commercialization.

Regulatory innovation and improvements aligned with global standards will be actively pursued. The MFDS will seek registration in international regulatory programs such as the World Health Organization (WHO) Listed Authorities and the Pharmacopoeial Discussion Group (PDG). In the domestic diagnostic kit and digital health sectors, where Korea is prominent, the MFDS plans to lead the establishment of international standards. Related to this, new technology medical devices such as digital and newly developed devices, in vitro diagnostic devices, and imaging diagnostic equipment are considered to have export comparative advantages. The MFDS will also promote the '333 Export Support' project over three years for 30 items in three product groups to create new global demand.

Amid a severe manpower shortage in the pharmaceutical and bio industries, expert training in the highly demanding regulatory science (RA) field will also be conducted. Through the Graduate School of Regulatory Science, the MFDS aims to train 600 master's and doctoral-level professionals and 24,120 industrial regulatory experts from 2023 to 2027.

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