China FDA issues guidelines for cell therapy testing

China FDA issued new guidelines concerning development and testing of cell therapy products, including stem cell treatments and immune cell therapies such as chimeric antigen receptor (CAR) T cell therapeutics.

The guidance outlines technical requirements to evaluate the safety, efficacy and quality control of cell therapy products and notes that since cell therapies derived from living cells differ from traditional pharmaceuticals, developers must take into account special considerations while still meeting general standards for pharmaceutical quality control. The guidance specifies that sponsors should develop a risk control plan that identifies risk factors associated with product quality and safety and describes specific steps for quality control and risk management...