Evolution of China's stem cell regulatory framework and review considerations for cell–biomaterial combination products
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REFERENCES
[1] Song S.J., Nam Y., Rim Y.A., et al. (2024). Comparative analysis of regulations and studies on stem cell therapies: focusing on induced pluripotent stem cell (iPSC)-based treatments. Stem Cell Res. Ther. 15:447. DOI:10.1186/s13287-024-04065-9 [2] State Council of the People's Republic of China. (2025). Regulations on the Administration of Clinical Study and Clinical Translation and Application of New Biomedical Technologies (Order No. 818). Effective May 1, 2026 [3] Development and Reform Commission of Shenzhen Municipality, & Science, Technology and Innovation Bureau of Shenzhen Municipality. (2026). Shenzhen Work Plan for Promoting High-Quality Development of the Cell and Gene Field ("Cell Ten Measures"). Issued April 3:2026 [4] National Medical Products Administration. (2021). NMPA Notice on Matters Concerning the Registration of Drug-device Combination Products (No. 52 of 2021). July 27, 2021 [5] -
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Chen Y., Ding J. and Liu B. (2026). Evolution of China's stem cell regulatory framework and review considerations for cell–biomaterial combination products. The Innovation Drug Discovery 1:100017. https://doi.org/10.59717/j.xinn-drugdisc.2026.100017
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Chen Y., Ding J. and Liu B. (2026). Evolution of China's stem cell regulatory framework and review considerations for cell–biomaterial combination products. The Innovation Drug Discovery 1:100017. https://doi.org/10.59717/j.xinn-drugdisc.2026.100017
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Figure 1.
International comparison of regulatory frameworks for stem cell products
