Overview of accelerated assessment and approval policies for cell and gene therapy products in the United States and Europe and its implications for China
WANG Jing
LU Shuang
Abstract：The rapid development of cell and gene therapy products carries the high expectations of industry,patients,and healthcare workers,and also poses a considerable challenge to drug regulatory authorities.In order to promote the development and marketing of these products with great therapeutic potential,the US and European drug regulatory authorities have adopted measures to adjust organizational structures,improve regulations and guidelines,and develop targeted accelerated procedures for cell and gene therapy products.China's regulatory policy for cell and gene therapy products is also constantly improving.By summarizing and analyzing the accelerated assessment and approval policies of the US and European drug regulatory agencies for cell and gene therapy products,this paper aims to provide reference for the optimization of the accelerated assessment and approval policies for these classes of products in China.
Keywords：cell and gene therapy productsaccelerated assessment and approval policiesdrug adminis-tration
Publication Date：2023-12-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2441-2446 )