China’s Decree 818 aims to bring hospital-based cell, gene and individualized therapies into the clinic safely. Its success will depend on whether it is consistently applied and whether adverse outcomes are reported, keeping patient safety at the forefront and holding institutions accountable for the results.
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https://doi.org/10.15302/vita.2026.06.0048(2026).State Council of the People’s Republic of China. Regulation on the Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies (State Council Decree No. 818) [in Chinese]. State Counci...