Korea is developing an AI–supported system to assist regulatory drug reviews. The initiative, led by the Ministry of Food and Drug Safety (MFDS), includes a task force to build generative AI tools that can help analyze regulatory submissions, automate repetitive review tasks, and detect errors before applications are filed. The AI review system will initially support areas such as active pharmaceutical ingredient (API) standards and bioequivalence assessments, with plans to gradually expand its use across all drug approval processes by 2028. The government aims to shorten review timelines and ultimately reduce standard approval periods to about 240 days. The effort complements a broader national AI strategy for the pharmaceutical sector announced by the Ministry of Science. Korea hopes the initiative will increase its new drug pipeline tenfold and enable up to 300 investigational new drug (IND) applications generated with AI support over the next five years.
While global pharmaceutical companies have primarily focused on sourcing assets in China, a similar trend is now emerging in Korea. Multinational drug companies are ramping up investments and partnerships in Korea’s growing biotech sector. Recent initiatives from Eli Lilly, Roche, and Johnson & Johnson highlight a focus on innovation and clinical trials. Samsung Biologics and Eli Lilly have partnered to launch a Korean site for Lilly Gateway Labs, an incubator supporting biotech startups. In parallel, Eli Lilly and Roche have pledged more than $900 million to advance drug development and expand clinical trial activity in Korea. These efforts are helping position Korea as an increasingly important center for pharmaceutical innovation and global clinical development in Asia.
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.