Korea is quickly expanding the use of AI in its drug regulatory and safety systems. Korea’s Ministry of Food and Drug Safety (MFDS) will start applying AI in drug review work starting next year as part of a wider attempt to innovate its regulatory review through the use of innovative technology. The National Institute for Food and Drug Safety Evaluation (NIFDS) of the MFDS will begin with the use of AI in routine and repetitive tasks such as sorting review data for synthetic chemical drugs. The agency will gradually increase the application of AI as additional data becomes available. At the same time, the Drug Research Division is also leveraging big data analytics on its overseas GMP inspection risk assessments. However, this effort remains hampered by weak and inconsistent standards of data at overseas manufacturing facilities. In addition to big data and AI, MFDS is also building targeted Korean-English translation models for drug and device safety documents.
At the same time, the Korea Institute of Drug Safety and Risk Management (KIDS) announced a new initiative to change its approach from manual pharmacovigilance to predictive pharmacovigilance. The initiative will include automating adverse event reporting, digital patient compensation, and building a real-time monitoring system from electronic medical records (EMRs). Over the next three years, the CDM platform will grow from 30 hospitals to 66 hospitals and include unstructured data in its monitoring process to improve pharmacovigilance monitoring.
KIDS will also introduce LLM-powered AI to provide better speed and reliability in safety reviews and release an AI-scaled chatbot to help patients with the drug damage relief system. Drug safety cards that currently exist on paper will be replaced by digital cards that update in real-time with cautions. The initiatives follow a significant spike in adverse event reports, with Korea now the world’s second-largest contributor to the WHO database. KIDS is also collaborating with overseas agencies to integrate domestic data into international systems in an effort to build a patient-centered lifecycle safety management model.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.