FDA Signals More Inspections of Foreign Clinical Trials
The US Food and Drug Administration plans to increase the frequency and intensity of Good Clinical Practice inspections for trials conducted outside the US, with a particular focus on China.
US Food and Drug Administration officials have signaled plans for more frequent and intense Good Clinical Practice (GCP) inspections of foreign clinical trials, including early-stage studies. In a recent article, leaders from FDA's drug, biologics, and device centers warned sponsors not to assume a lower probability of inspection for studies conducted abroad and pledged to increase resources for the agency's Bioresearch Monitoring program.
This policy shift aligns with broader US government initiatives to onshore clinical research and expresses heightened concern over data integrity and patient consent, particularly in China. The development creates significant uncertainty for pharma and biotech companies that rely on foreign clinical trials for speed and scale. Sponsors now face a greater risk that data from ex-US studies could be rejected, delaying or preventing US market access. The heightened regulatory risk also complicates M&A and licensing diligence for assets supported by foreign clinical data. Companies should ensure all trials, regardless of location, are conducted as if they will face FDA inspection and monitor proposed legislation that could further restrict the use of data from China and other designated countries.