Introduction of AI for drug approval and review in Korea

...phased implementation expected starting next year

National Institute of Food and Drug Safety Evaluation’s Pharmaceutical and Medical Device Research Department focuses on vaccine evaluation technology development

Herbal Medicine Center to distribute standardized herbal medicine products by category...five new items to be added annually

The Ministry of Food and Drug Safety is conducting follow-up research to introduce generative artificial intelligence (AI) to the domestic drug approval and review field starting next year.

 

The Pharmaceutical and Medical Device Research Department of the National Institute of Food and Drug Safety Evaluation is conducting an ISP project to establish the system, and plans to gradually expand the scope of AI application from chemical drugs to biopharmaceuticals.

 

The Pharmaceutical and Medical Device Research Department of the National Institute of Food and Drug Safety Evaluation met with MFDS press corp reporters at the Jeju National Herbal Resource Management Center presented initiatives including research using AI and big data, the development of impurity analysis methods for pharmaceuticals, evaluation technologies for biological products, and plans to distribute standardized herbal reference substances.

 

(From the left) Kyung-hoon Son, Director of the Drug Research Division;, Cheol-hyun Lee, Director of the Biologics Research Division; Gidae Park, Acting Director, Division of Advanced Biopharmaceutical Research; Jinhee Hwang, Director, Herbal Medicine Research Division; Youngmi Song, Director, Cosmetics Research Division; Haedae Park, Director, Division of Medical Device Research

On the day, Jiwon Jeong, Director-General of the Pharmaceutical and Medical Device Research Department, opened the meeting with an explanation of the current status of research related to artificial intelligence and big data.

 

Jeong said that new projects being promoted this year include research on strategies for utilizing AI in drug reviews.

 

Director-General Jeong explained, “It is a two-track approach: the AI system is being developed by the IT team, while we are researching to determine whether AI can be used in medical product reviews.” She added, “The process of introducing AI into medical product reviews requires an enormous amount of data, so it is difficult to initiate everything at once.

 

Starting next year, we will implement the project in phases, beginning with the simple and repetitive task of preparing review materials.

 

We will start with chemical drugs.” Kyung-hoon Son, Director of the Drug Research Division, then discussed research on utilizing big data in the course of developing technology for assessing the safety of overseas manufacturing facilities related to Good Manufacturing Practice (GMP) standards.

 

Director Son explained, “We conduct on-site inspections of overseas manufacturing facilities every year, but since each facility has its own system, there are challenges in organizing the data.

 

Through this research, we aim to develop technology to standardize data related to GMP to assist with overseas inspections.” He also noted, “This research utilizing big data has not yet progressed to the stage of using AI.

 

Even without collaborating with overseas companies, we believe it will be possible to develop and utilize a model that utilizes big data domestically.” In addition, the Pharmaceutical and Medical Device Research Department is promoting research on the development of specialized translation models (Korean-English) for safety management in the field of pharmaceuticals, the application of next-generation advanced pharmaceutical innovation technologies such as AI to manufacturing facilities, and a model for the utilization and dissemination of public data based on adverse drug reaction reports.

 

(from the left) Jiwon Jeong, Director-General of the Pharmaceutical and Medical Device Research Department, Kyung-hoon Son, Director of the Drug Research Division, Cheol-hyun Lee, Director of the Biologics Research Division

◆ Research on impurity analysis methods expanded to include new substances=The National Institute of Food and Drug Safety Evaluation is also conducting research on the safety management of impurities and infectious diseases in pharmaceuticals.

 

This includes developing and providing impurity analysis methods, developing and publishing impurity safety management guidelines, and compiling and distributing case studies on impurity occurrence assessments.

 

In this regard, Director Son said, “The current research focuses on how to reduce single impurities such as N-nitrosodimethylamine (NDMA),” adding, “We are also conducting research on simultaneous analysis methods in consideration of small-sized companies.” He emphasized, “In particular, since the beginning of this year, we have been analyzing and categorizing the characteristics of newly developed substances, not just single substances, to develop analysis methods.

 

Although the results are not yet available, we are striving to manage impurities that did not exist before.” The development of evaluation technologies for biological products is a research area currently being pursued by the National Institute of Food and Drug Safety Evaluation to strengthen infectious disease control.

 

Biological products include mRNA vaccines, antibody-drug conjugates (ADCs), and antibody-based therapeutics such as monoclonal antibodies, bispecific antibodies, and small-molecule–multi-specific antibody combinations.

 

Cheol-hyun Lee, Director of the Biologics Research Division, explained, “We have been conducting research on delivery methods and materials for mRNA vaccines for about 5 years, and we expect to complete the research this year.” He added, “We have not developed evaluation technologies for specific products or indications in the field of antibody drugs, but are creating relevant guidelines and information booklets.

 

We are indirectly supporting companies' relevant research and development through methods such as introducing overseas cases.”

Jeju National Herbal Resource Management Center

◆ National Herbal Resource Management Center owns 396 standardized herbal reference materials = The National Institute of Food and Drug Safety Evaluation is also creating standard herbal medicine products through the National Herbal Resource Management Center.

 

Located in three locations, Yanggu-gun, Gangwon-do; Okcheon-gun, Chungcheongbuk-do; and Seogwipo-si, Jeju-do, the National Herbal Resource Management Center serves as a control tower for the preservation, research, and investigation of herbal medicine resources in Korea.

 

According to data from the National Institute of Food and Drug Safety Evaluation, the National Herbal Resource Management Center currently has 396 standardized herbal reference materials, including 273 standard herbal items, 120 marker compounds, and 3 reference materials.

 

This is an increase of 12 items compared to 384 in 2023.

 

Jin-hee Hwang, Director of the Herbal Medicine Research Division, said, “About five standard products are added every year.

 

Although no products have been successfully commercialized, research using standard products is ongoing at Jeju Techno Park and Jeju University laboratories.” Additionally, the distribution of standardized herbal reference materials will not be categorized by sector such as pharmaceuticals, health functional foods, or cosmetics, but rather based on their intended use, such as quality control or research and development.

 

The National Herbal Resource Management Center is currently working to improve the distribution system and plans to implement sector-based distribution, including for pharmaceuticals, starting next year.