New regulations for clinical trials of Chinese innovative drugs to take effect in September

The newly revised Good Clinical Practice for Drugs was released on June 8 and will take effect on September 1. The new rules emphasize "quality by design," "fit for purpose," and "riskproportionate," requiring clinical trials to prevent problems as much as possible at the design stage rather than correcting them after the fact. The report cited relevant data as saying that in 2025, newly launched innovative drug clinical trials in China accounted for 48% of the global total, with about 2,500 trials for the year, up 20% year on year. Industry insiders said that the proportion of earlystage trials in China’s innovative drug clinical research continues to rise, and independent R&D capability as well as trial resources are also strengthening. The article also mentioned that Chinese clinical trial data are increasingly being used by international regulatory agencies in new drug approvals. The national drug regulatory authority said that the new version of GCP will define the compliance boundaries for drug clinical trials, while encouraging the industry to adopt new technologies and new methods under the premise of compliance, and promote the modernized development of drug clinical trials.