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CAR T boom expected

CFDA opens door for national approval of cell therapy trials as drugs

By Shannon Ellis
Staff Writer

Wednesday, January 10, 2018

SHANGHAI – The CFDA recently released "Guiding Principles for the Research and Evaluation of Cell Therapy Products" for trial implementation. This hotly anticipated move now adds cell therapies – such as stem cells and chimeric antigen receptor (CAR T) therapies – under the umbrella of CFDA reforms that are aligning China's drug regulations with global drug markets. The guidelines set out standards for the approval of clinical trials for cell therapies and opens the door to a viable path to commercialization of cell therapies to be regulated by the CFDA, much like other new drugs.

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