基于已上市药品变更管理制度下的CAR-T细胞治疗产品上市后的变更管理与挑战

Post-approval change management and challenges of CAR-T cell therapy products based on the approval drug change management system

目的:为我国细胞治疗产品(cell therapy products,CTP)上市后变更管理制度的优化实施提供参考。方法:简单介绍了目前中国已上市药品变更管理政策(以下简称“变更”),结合梳理目前企业CTP变更管理方法,讨论分析CTP已上市企业面临的挑战。结果与结论:CTP企业在研发上市时应逐步建立变更控制体系,不断提升变更管理。而对于药监部门,希望兼顾行业发展,考虑CTP的特殊性,生产监管与注册监管紧密配合,尽早出台CTP变更相应的指导原则,增进企业与监管交流,提升CTP全生命周期的监管规范。

Objective:To provide reference for the optimization and implementation of post-approval change management system of cell therapy products(CTP)in China.Methods:The change management policy of currently approved drugs in China(hereinafter referred to as“change”)was briefly introduced and the challenges faced by CTP marked enterprises were discussed and analyzed by sorting out the change management methods of current corporate CTP.Results&Conclusion:CTP enterprises should gradually establish change control system during R&D and marketing so as to continuously improve change management.For drug regulatory authorities,we expect that they can take into account the development of the industry,consider the particularity of CTP,closely cooperate with production supervision and registration supervision,issue corresponding guidelines for CTP changes as early as possible,and enhance the exchange between enterprises and supervision so as to improve the regulatory specifications for the whole life cycle of CTP.