Stem cell-derived therapeutic products are treated as medical products. Strigent regulations for medical products are applied on preclinical and clinical development of these products. This track aligns with US FDA’s regulations for cell theapies. Once approved, these products can be used in many hospitals across China.
The first stem cell-based product, Amimestrocel, was approved in China for treatment of GvHD after hematopoietic stem cell transplantation, but because of the change in classification later on by ISSCR, that product may not be classfied as stem cell-based products anymore.
Stem cell-derived therapeutic products are treated as various types of new biomedical technologies. China National Health Commision encourages AAA hospitals to initiate clinical research based on solid preclinical studies. Once safey and afficacy are validated by clinical research in a hospital, the cell therapy is approved for that specific hospital. People in the cell therapy industry in China often call this track the 818-regulation track, because it was the 818th decree of the State Council when promulgated by the State Council in September of 2025. The regulation is entitiled “Regulations on Administration of Clinical Research and Clinical Translational Application of New Biomedical Technologies” and will be enter into force on May 1 of 2026.
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