细胞和基因治疗产品监管科学研究进展和展望

Progress and prospect of regulatory science in cell and gene therapy products

细胞和基因治疗是国内外生物医药产业未来发展的主要方向之一。从2019年开始,国家药品监督管理局启动中国药品监管科学行动计划,将细胞和基因治疗纳入监管科学研究的重点领域。经过2年多的研究工作,细胞和基因治疗的监管科学研究取得了一系列成果,有力地提高了监管部门的管理和服务水平。本文简要介绍监管科学行动计划实施以来,细胞和基因治疗重点项目取得的进展,并探讨未来工作的计划和展望。

Cell and gene therapy has become the next frontier of biopharmaceutical industry.National Medical Products Administration launched drug regulatory science action in 2019,the key area of which includes cell and gene therapy.After more than two years of effort,remarkable progress has been achieved in the regulatory scientific research of cell and gene therapy,which effectively improved the management and service capability of regulatory departments.In this article we briefly introduced the progress in the regulatory scientific research of cell and gene therapy since the implementation of the regulatory science action,and discussed future research projects and prospects.