China tightens rules for fast-track clinical trials after two child deaths

September 8, 2026 at 03:00 PM1 min

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China's Order 818, effective May 1, restricts investigator-initiated trials of new biomedical technologies to top-tier sanjia hospitals. The regulation follows reports that two children died after receiving gene-editing treatments in separate clinical trials. The move aims to increase oversight of a fast-track pathway that has driven growth in cell and gene therapy research.

Key Facts

Order 818, effective May 1, restricts investigator-initiated trials of new biomedical technologies to sanjia hospitals.
Two children died after receiving gene-editing treatments in separate clinical trials in China in the past two months.
The number of annually registered investigator-initiated trials in cell and gene therapies grew 11-fold to 207 between 2015 and 2023.
Previous rules required stem-cell therapy trials to be conducted at sanjia hospitals, but enforcement was inconsistent.

The New Regulation

Order 818 governs investigator-initiated trials that use new biomedical technologies, including cell therapies, brain implants, and gene-editing treatments. Under the order, only sanjia hospitals—China's top research and training hospitals—are permitted to conduct such trials. The regulation aims to increase regulatory oversight of these trials, according to Hao Bin, an economist at Xi'an Jiaotong-Liverpool University in Suzhou. The order went into effect on May 1, months after the government introduced stricter rules for investigator-initiated trials.

Background and Impact

Investigator-initiated trials are widely considered a driving force behind China's rising competitiveness in biomedicine, particularly for cell and gene therapies. The number of annually registered investigator-initiated trials in this area grew 11-fold to 207 between 2015 and 2023. Previous rules required stem-cell therapy trials to be conducted at sanjia hospitals, but enforcement was inconsistent, leading to a grey market of unauthorized therapies. In some cases, this grey market led to medical accidents and even deaths, according to researchers and industry insiders.