New rules spur cell and gene therapy trials in China

China has reorganized its rules for clinical trials, with the aim of positioning itself as a key country for the first cell and gene therapies. The changes, which will take effect in May, will incentivize hospitals to initiate and conduct cell and gene therapy trials while improving trial standards.

Until now, clinical trials of cell and gene therapies in China have focused only on early-stage experimental treatments. Such experimental trials have tested therapies made in-house at hospitals and are led by investigating doctors and regulated by health authorities, without input from the country’s national drug regulator. The impending rules will now regulate these trials: adding rigor to the existing green light system, allowing trials to be conducted only by large teaching and research hospitals, and requiring both scientific review and ethics committee approval.