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Overview of accelerated assessment and approval policies for cell and gene therapy products in the United States and Europe and its implications for China
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Jing WANG, Shuang LU
Chinese Journal of New Drugs | 2023, 32(24) : 2441 - 2446
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Chinese Journal of New Drugs | 2023, 32(24): 2441-2446
Overview of accelerated assessment and approval policies for cell and gene therapy products in the United States and Europe and its implications for China
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Jing WANG, Shuang LU
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2023-12-30
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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.

cell and gene therapy products  /  accelerated assessment and approval policies  /  drug administration
Jing WANG, Shuang LU. Overview of accelerated assessment and approval policies for cell and gene therapy products in the United States and Europe and its implications for China[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2441 -2446 .
Year 2023 volume 32 Issue 24
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  • Online Date:2026-03-05
  • Published:2023-12-30
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History
  • Accepted:2023-11-15
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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