Recent Trends in the Regulation of Biopharmaceuticals in Korea

As the development and approval of biopharmaceuticals in Korea continues to increase, the Ministry of
Food and Drug Safety (MFDS) is playing a pivotal role in bringing safe and effective biopharmaceuticals to
patients in a timely manner.
The MFDS has been driving many changes in its regulatory pathways, including the enactment of new laws
for ATMPs and the introduction of expedited programs.
My talk will focus on the current landscape of biopharmaceutical development and recent regulatory
changes introduced by the MFDS to spur further advancement of biopharmaceuticals in Korea. More
specifically, I will address the amendments to the Korea Pharmacopeia in 2019 and 2020, the status of
biosimilar development, and issues currently under discussion that MFDS regulators have encountered in the
quality review of biopharmaceuticals.