FDA Commissioner Marty Makary warned that the U.S. is losing ground to China in drug development, with China now conducting more clinical trials and accounting for nearly a third of new global drug approvals.23
Makary called for reforms to streamline the process for starting new drug trials and urged the Trump administration to partner with the pharmaceutical industry.3
In a New England Journal of Medicine article, FDA leaders proposed accepting a single well-designed confirmatory clinical trial for drug approval, down from the traditional two, to accelerate approvals and reduce costs.1
China's NMPA shortened clinical trial application reviews to 30 days (further to 20 days by May 2026) and plans to accept overseas clinical data, grant monopolies for first-to-market drugs, and allow sales before completing Phase 3 for innovative drugs.1
Sources:
1. https://www.chosun.com/english/industry-en/2026/02/26/S2VWG5FRHVC53FB2A5U4IM3554/
2. https://firstwordpharma.com/story/7108903
3. https://stocktwits.com/news-articles/markets/equity/fda-commissioner-raises-concerns-about-us-pharma-lagging-behind-china-in-drug-development/cZRKIGlR4wT