收藏切换
Interpretation of guidance on CMC study of in vivo gene therapy products
收藏切换
PDF
Long-chang XU, Jing CUI, Wu HE
Chinese Journal of New Drugs | 2023, 32(2) : 113 - 117
Less
收藏切换
Chinese Journal of New Drugs | 2023, 32(2): 113-117
Interpretation of guidance on CMC study of in vivo gene therapy products
Full
Long-chang XU, Jing CUI, Wu HE
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-01-30
Outline
收藏切换

The guidance on CMC study of in vivo gene therapy products was issued by the Center for Drug Evaluation, NMPA, on May 26, 2022, to encourage and promote the development of in vivo gene therapy products. This paper gives a detailed interpretation of the main contents and some important issues of the guidance and provides a reference for the market authorization application, combined with the drafting process of the guidance, so that the industry can better understand the technical requirements of the guidance during the development of in vivo gene therapy products.

in vivo gene therapy  /  CMC research  /  market authorization application
Long-chang XU, Jing CUI, Wu HE. Interpretation of guidance on CMC study of in vivo gene therapy products[J]. Chinese Journal of New Drugs, 2023 , 32 (2) : 113 -117 .
Year 2023 volume 32 Issue 2
PDF
39
8
Cite this Article
BibTeX
Article Info
  • Online Date:2026-03-05
  • Published:2023-01-30
Article Data
Affiliations
History
  • Accepted:2022-12-09
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
References
Share
https://castjournals.cast.org.cn/joweb/zgxyzz/EN/
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
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
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT