China releases draft guidance on stem cell research

China FDA released draft guidance that establishes a new pathway and infrastructure for managing stem cell research in the country. The agency is accepting comments until April 10.

Previously, there were two pathways. CFDA granted authorization to companies running trials of stem cell therapies that would become drugs, and the National Health and Family Planning Commission (NHFPC) granted authorization for therapeutic stem cell procedures on a patient-by-patient basis under a high-risk medical technology classification. ...