BioCentury
ARTICLE | Clinical News

China strengthens clinical trial approval regulations

February 27, 2019 11:25 PM UTC

China’s National Health Commission released draft regulations on Wednesday outlining new clinical trial approval processes for "high-risk" cellular and molecular therapeutic technologies that will increase supervision of the therapies.

High-risk technologies as defined by State Council health authorities include gene editing, stem and somatic cell therapies, mitochondrial replacement, use of xenogeneic biological materials, genetically modified flora transplantation and assisted reproductive technology...