FDA Commissioner Marty Makary warned U.S. policymakers and industry that the country is losing competitiveness in early‑stage drug development to China, citing bottlenecks in hospital contracting, ethical review and IND submission processes. Makary urged process reforms and public‑private collaboration to accelerate trial starts. At the same time, Chinese regulators unveiled draft rules to speed clinical trial reviews, mandate 20‑working‑day decisions on applications, and introduce accelerated approval pathways — measures Beijing says will promote clinical value‑oriented drug development. The paired developments indicate intensifying regulatory competition and underscore the strategic urgency for governments and sponsors to streamline trial activation.