The U.S. FDA is considering a plan to drastically ease new drug approval procedures. In an article contributed to the international academic journal NEJM, FDA Commissioner Marty Makary and CBER Director Vinay Prasad stated, "In the future, a single well-controlled clinical trial may be sufficient to meet the basic requirements for new drug approval." Previously, two confirmatory clinical trials (Phase 3) were mandatory, but reducing this to one would significantly shorten development time and costs. This represents a revolutionary change, considering that developing one new drug typically takes over 10 years, and the daily cost of a Phase 3 clinical trial alone amounts to $55,700 (approximately 80 million Korean Won). China is also responding with its own measures. The China NMPA has already reduced the review period for clinical trial applications from 60 days to 30 days, and will further shorten it to 20 days starting this May. Furthermore, China is legally establishing a 'new drug development fast-track' system that allows sales approval even before the completion of Phase 3 clinical trials, and is eliminating the process for recognizing overseas clinical data within China. The first companies to launch products will also be guaranteed exclusive sales rights for 2 years for pediatric drugs and 7 years for orphan drugs. This simultaneous regulatory easing by the U.S. and China is interpreted as part of the intensifying rivalry for global dominance, which has now spread from semiconductors to the biotech sector. For K-biotech companies, the easing of FDA clinical barriers could directly benefit them in terms of global market entry costs and speed. At the same time, however, the rapid growth of China's biotech industry presents a growing challenge.