A new regulation issued by China’s State Council outlines, for the first time, clear rules for the study and use of advanced biomedical technologies, including gene editing, CAR-T and NK cell therapies, as well as stem cell treatments.
The Regulations on the Administration of Clinical Study and Clinical Translation and Application of New Biomedical Technologies were published in October and will take effect on May 1, 2026. The new framework is designed to promote innovation while ensuring safety and ethical standards in this fast-growing field.
Research on biomedical technologies will no longer have to go through an approval process, but instead will be subject to a filing-based review process. In other words, after passing ethical and academic reviews, studies can be filed with the authorities for further action, accelerating the pace of research. The National Health Commission (NHC) will, however, have overall supervision over such research and can suspend it on safety or ethical grounds.
When it is ready for clinical use, a technology is taken through an approval process, which ascertains whether it is safe and effective. Once approved, all hospitals will be allowed to provide these technologies to patients, billing for them under existing regulations. Thus, a new path to commercialization will open for advanced biomedical technologies, instead of going through the traditional drug and medical device approval routes.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.