细胞和基因治疗(cell and gene therapies,CGTs)受到国际社会的广泛重视并取得快速发展,科学监管有益于促进行业良性有序发展.本文通过政策系统梳理,结合主要历史事件勾勒了我国CGTs监管政策的调整脉络和历史沿革,大致将我国CGTs的监管历程分为4 个时期:跟随探索期(1993-2005 年)、监管真空期(2005-2008 年)、乱象整顿期(2009-2018 年)以及科学监管期(2019 年至今).同时,对各时期的政策导向和问题进行了系统综述.最后,对比国际先进经验,从中寻求有益启示并对未来进行展望.
The historical evolution and perspective of the regulation on cell and gene therapy products in China
Cell and gene therapies(CGTs)have received extensive international attention and gained development,and scientific supervision is beneficial for promoting the industrial development healthy and in order.This paper outlines the adjustment context and historical evolution of China's CGTs regulatory policy through policy systematization and major historical events,and roughly divides the regulatory process of CGTs in China into four stages:the exploration stage(1993-2005),the regulatory vacuum stage(2005-2008),the chaotic rectification stage(2009-2018),and the scientific supervision stage(2019 to present).Meanwhile,the policy orientation and problems in each stage are systematically reviewed.Finally,the international advanced experience was compared to seek useful inspiration and to look into the future.
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