Two Republican lawmakers asked the FDA to reject clinical data from China unless trial sites have been recently audited by the agency, and to review existing products’ reliance on Chinese studies. The request comes amid renewed scrutiny of China’s “fast” investigator-initiated trial system and high-profile trust concerns. The lawmakers’ proposal would effectively tighten evidentiary standards for multinational submissions and could affect timelines for programs relying on China-based enrollment and clinical operations. The FDA has not indicated how it would implement any such changes. For sponsors, the development highlights an increasing risk-management need around data provenance, audit history, and submission defensibility.