China tightens oversight of fast-track biotech trials amid safety concerns

China’s National Health Commission introduced Order 818 on May 1, tightening regulation of investigator-initiated trials that use emerging biomedical methods such as cell and gene therapies. The order restricts these studies to top-tier “sanjia” hospitals and gives the commission authority to request a second assessment, halt, alter or cancel trials that raise technical or ethical concerns. Violations can result in multi-million-yuan fines, a three-year ban on future trials, and possible revocation of physicians’ licences.

The change responds to earlier lax supervision that permitted many trials in private clinics and non-top hospitals, contributing to medical mishaps and some deaths. Analysts note the measure could rebuild public trust but may slow innovation if applied too rigidly, while allowing companies to initiate IITs directly could improve industry collaboration under the new oversight framework.