China moves to better regulate clinical trial pharmaceutical risks

Moving to improve the safety of clinical trials, China’s Center for Drug Evaluation (CDE) has drafted new regulations on the timing, duration, and manner in which such trials are conducted. Under the new regulations, clinical trials would need to be initiated within three years after they are approved, with regular reports on risks and adverse reactions submitted regularly to the CDE. Trials judged by the CDE to pose a significant risk to patients could be terminated.