China has revamped its clinical trial rules, aiming to position itself as a go-to country for early cell and gene therapies. The changes, which will come into effect in May, incentivize hospitals to take on and run cell and gene therapy trials while also improving trials’ standards.
So far, clinical trials for cell and gene therapies in China have been for early-stage, experimental treatments only. Such investigational trials have tested therapies made in-house at hospitals and are led by physician-investigators and regulated by health authorities, without input from the country’s national drug regulator. The impending rules will now regulate such trials: adding rigor to the existing rapid go-ahead system, allowing trials to be carried out only by large teaching and research hospitals, and requiring both scientific review and ethics committee approval.
— Source: Nature Biotechnology (https://www.nature.com/articles/s41587-026-03065-9)
