New rules add rigor while fueling China’s gene and cell therapy engine

Regulations set to take effect May 1 are poised to accelerate China’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. The rules establish a unified governance framework for conducting clinical research,  translating therapies into routine clinical practice, and commercializing those products at a limited scale. The paradigm adds regulatory rigor while preserving the fast timelines that have made IITs a competitive advantage for China.

The legal framework reinforces China’s role as a destination for conducting first-in-human trials that can de-risk complex therapeutic modalities that have been struggling to attract investment in the U.S. and Europe. ...