China, the first country worldwide to approve a gene therapy in 2003, almost lost the advantage for a head start in cell and gene therapy (CGT) development due to a lack of clear and strict regulatory frameworks. The rapid advancements of CGTs' development worldwide as well as their therapeutic potential have triggered the government to conduct a spate of regulatory reforms to promote normative development of CGTs in China. Encouraged by policy support, the remarkable progress for CGTs in China has been observed over the past few years, thereby catapulting China back into the forefront of CGTs worldwide. This article aims to provide an overview of regulatory reforms, the current development landscape of CGTs, as well as key contributors and challenges for CGT development in China.
Keywords: CART; China; cell and gene therapy; clinical trials; regulatory.