Research on innovative regulatory pathways for cell and gene therapy products
YANG Li
HUANG Ge-yun
ZHANG Jie
WANG He-huan
Abstract：Objective:To propose targeted recommendations for enhancing the regulatory innovation pathways for cell and gene therapy(CGT)products in China.Methods:This study employed a comprehensive literature review to examine the research and development characteristics,regulatory requirements,and innovation pathways for CGT products in China,the United States,Europe,and Japan.Additionally,a statistical analysis was conducted to compare the implementation outcomes of regulatory innovation pathways for these products across the aforementioned regions.Results:In comparison to the United States,the European Union,and Japan,the regulatory pathways for CGT products in China requires further enhancement.The diversity of CGT products available in China is relatively limited,and the therapeutic application range is narrow.Although the overall development timeline is the shortest,the review period is longer in China than that observed in the United States and Japan.Conclusion:It is recommended that China should elucidate the approval pathways and standards for CGT products,establish a specialized department for the supervision and evaluation of CGT products,enhance the construction of an evidence-based system for CGT products development,create targeted expedited market approval programs for CGT products,implement a qualification recognition mechanism for CGT products,and strengthen post-market surveillance of CGT products in China.
Keywords：cell and gene therapy productsregulatory pathwaysinnovation
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：9( 2467-2475 )