The historical evolution and perspective of the regulation on cell and gene therapy products in China
JIANG Lu-yi
KANG Qi
JIN Chun-lin
Abstract：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.
Keywords：cell and gene therapyregulatory scienceprospect
Publication Date：2024-12-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 2462-2466 )