China Clarifies Stem Cell Clinical Research Regulations

Liu Zhongming, director of the Shanghai Stem Cell Clinical Translation Research Institute, explained new regulatory pathways for biomedical frontiers. China has implemented new regulations covering gene therapy, somatic cell therapy, and stem cell treatments. The National Medical Products Administration has approved 14 cell and gene therapy drugs for market entry and granted clinical trial permits for several cell therapy products as of April 2026. These regulations aim to formalize the dual-track path of drug development and medical technology application. The new approach aims to bring stem cell clinical research and applications into a more transparent regulatory framework. These medical techniques involve applying biological principles at the cellular and molecular levels to treat or prevent diseases. Former President Liu Zhongming explained that the country previously used a dual-track path involving drug development approvals and hospital-led clinical research. This regulation establishes a clear pathway for transitioning research into clinical use. New regulations, specifically Order No. One path involves drug research and development approval for market entry, while the second allows for clinical trial applications led by enterprises or clinical research projects led by hospitals.