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Cell therapy products (CTPs) have become a highly promising area within the realm of regenerative medicine research in China. In recent years, there has been a notable increase in the demand for new drug applications related to these innovative products. However, the diverse range of sources, biological functions, product types, and technologies associated with CTPs present considerable regulatory challenges. This article delves into how regulatory authorities in China have been continuously refining their frameworks, enhancing quality evaluation abilities, and fostering open communication and collaboration with the industry to tackle these challenges. These ongoing regulatory efforts have played a crucial role in facilitating the healthy and rapid growth of the clinical translation of CTPs in China.

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Development of Regulation and Policy for Cell Therapies in China

  • 章节

  • 发表日期：

    2025年

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  • Tao Na,
  • Kehua Zhang,
  • Zhaohui Wu,
  • Xuelin Wu,
  • Tingting Wu,
  • Xiaoyan Han,
  • Wen Zhang,
  • Miao Xu,
  • Shufang Meng

摘要

Cell therapy products (CTPs) have become a highly promising area within the realm of regenerative medicine research in China. In recent years, there has been a notable increase in the demand for new drug applications related to these innovative products. However, the diverse range of sources, biological functions, product types, and technologies associated with CTPs present considerable regulatory challenges. This article delves into how regulatory authorities in China have been continuously refining their frameworks, enhancing quality evaluation abilities, and fostering open communication and collaboration with the industry to tackle these challenges. These ongoing regulatory efforts have played a crucial role in facilitating the healthy and rapid growth of the clinical translation of CTPs in China.