China rewrites its regulatory framework for stem cell clinical translation
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Updated: Nov 7, 2026

Cortical Neurogenesis: Transitioning from Advances in the Laboratory to Cell-Based Therapies
Published on: July 19, 2007
Ruohan Feng1, Xue Pang1, Yi Hao2
1State Key Laboratory of Organ Regeneration and Reconstruction, Institute of Zoology, Chinese Academy of Sciences, Beijing 100101, China; Beijing Institute for Stem Cell and Regenerative Medicine, Beijing 100101, China.
Abstract:
China's 2026 reform creates a new dynamic regulatory architecture for stem cell and other advanced biomedical technology research and translation that moves these areas beyond the drug-versus-technology divide. Through revocable clinical-use authorization, life cycle surveillance, and mandatory exit, it seeks to align clinical access with safety oversight and evidentiary validation.
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