Home > Browse Issues > Vol.48 No.1
Progress in Regulatory Science for Cell and Gene Therapy Products Domestically and Internationally
GUO Jingli, GAO Jianchao, BIAN Lianlian, GE Sixiang, GAO Chenyan*
(Changping Laboratory, Beijing 102206, China)
Abstract:
Cell and gene therapy is among the key future directions of the global biomedical industry. Regulatory frameworks for these products across countries combine scientific rigor with regional characteristics. This article provides a brief overview of the regulatory approaches for cell and gene therapy in Europe, the United States, and Japan. It also reviews the evolution and refinement of China’s regulatory system since the 1990s, analyzes progress in regulatory science research, and discusses existing challenges along with potential future research directions.
CN
EN