Regulations on cell therapy products in China: a brief history and current status

Written by Regenerative Medicine

In this special report, published in Regenerative Medicine, discover the changing landscape of cell therapy product regulations in China. This article has been made free exclusively for members of RegMedNet. In this report, an international team of researchers from China and Maryland describe changes to cell therapy research and clinical practice in China following guidelines from the central government finalized at the end of 2017.Under the new regulations, cell therapy products are treated like drugs, in alignment with policy in the USA and European Union. At civil institutions in China, there are now two pathways for human clinical trials: research versus...

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