MFDS Visits Samba and Lotba in Series... "Listening to Voices from the Bio CDMO Field"

The Ministry of Food and Drug Safety (MFDS) took time to hear directly from the field in Songdo, Incheon, where contract development and manufacturing organizations (CDMOs) for biopharmaceuticals are concentrated, as part of regulatory innovation efforts.

On the 29th, participants including Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, and Lee Won-jik, CEO of Lotte Biologics (third from the left in the front row), are taking a commemorative photo at the Bio-pharmaceutical CDMO Regulatory Innovation Meeting held at Lotte Biologics' Songdo office.
[Photo by Ministry of Food and Drug Safety]

On the 29th, the MFDS announced that it held a meeting at the Lotte Biologics Songdo office in Yeonsu-gu, Incheon. In addition to Lotte Biologics, participants included Sartorius Korea Biotech, STGen Bio, Ilyeon Pharmaceutical, GC Cell, CHA BioLab, Janssen Korea, and Hanmi Pharmaceutical, who shared their opinions.

The global biopharmaceutical CDMO market is currently expected to grow from approximately 25 trillion KRW last year at an average annual growth rate of 12.2%, reaching a scale of 36 trillion KRW by 2026. Accordingly, the MFDS explained that this meeting was organized to discuss and explore support measures for domestic CDMO companies and ways to promote exports.

At the meeting, MFDS Commissioner Oh Yu-kyung stated, “If we utilize the biopharmaceutical CDMO infrastructure we possess, we can certainly leap forward as a global hub for biopharmaceutical production,” adding, “If the industry leads and the MFDS supports, in the near future, products we manufacture will lead overseas markets.” She continued, “We will review the various opinions derived from today’s meeting and reflect them in the biopharmaceutical policy direction,” and “We will prepare regulatory support measures to increase biopharmaceutical exports.”

Prior to the meeting, the MFDS visited the Songdo plant of Samsung Biologics, which has the world’s largest CDMO production facility. Commissioner Oh inspected the biopharmaceutical manufacturing site and the operation status of Good Manufacturing Practice (GMP) standards, listening to voices from the field. She said, “Samsung Biologics is supplying high-quality biopharmaceuticals worldwide and widely promoting the strength of K-Bio,” and added, “I hope they continue to strictly manage quality while complying with GMP standards.”