Home Journals Articles Updates About
CN
image
收藏切换
Overall analysis of new Chinese herbal drug approval and registration in recent years
收藏切换
Feng HONG1, Dan-dan CHU1, Hui-fang XU1, Lin MA1, Hao LI1, Wei LIU1, 2
Chinese Journal of New Drugs | 2021, 30(14) : 1260 - 1265
Less
收藏切换
Chinese Journal of New Drugs | 2021, 30(14): 1260-1265
Overall analysis of new Chinese herbal drug approval and registration in recent years
Full
Feng HONG1, Dan-dan CHU1, Hui-fang XU1, Lin MA1, Hao LI1, Wei LIU1, 2
Affiliations
  • 1Beijing University of Chinese Medicine, School of Management, Beijing 100029, China
  • 2Beijing University of Chinese Medicine, Achievement Transformation Center, Beijing 100029, China
Published: 2021-07-30
Outline
收藏切换

The paper analyzed the status quo of new Chinese herbal drug (NCHD) approval and registration in recent years, discussed the characteristics and existing problems of NCHD, then provided feasible suggestions. From 2012 to 2019, the number of NCHD approval showed a downward trend, but the approval rate increased. From 2015 to 2020, the number of NCHD registration decreased significantly, the number of category 6 new drugs had the largest number of registration, and there was no registration of category 2 and new drugs of category 4. The regional distribution of declaration units was obvious, the top 5 regions accounting for 48% of the total number of applications. The new drugs were mainly oral preparations, and the treatment field was concentrated in major common diseases. The sources of NCHD were mainly clinical prescriptions and scientific research achievements of scientific research institutions. In general, the quality of NCHD application has been improved, but the amount is at low tide. All stakeholders need to take multiple measures to promote the research and development of NCHD.

new Chinese herbal drug  /  approval  /  registration  /  status quo  /  analysis
洪峰, 褚丹丹, 徐慧芳, 马琳, 李浩, 刘伟. 近年我国中药新药审批及注册申请现状分析. 中国新药杂志, 2021 , 30 (14) : 1260 -1265 .
Feng HONG, Dan-dan CHU, Hui-fang XU, Lin MA, Hao LI, Wei LIU. Overall analysis of new Chinese herbal drug approval and registration in recent years[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1260 -1265 .
Appendix
Less
Year 2021 volume 30 Issue 14
47
10
Cite this Article
BibTeX
Article Info
  • Online Date：2026-10-28
  • Published：2021-07-30
Article Data
Affiliations
History
  • Accepted：2021-05-13
Funding
Affiliations
    1Beijing University of Chinese Medicine, School of Management, Beijing 100029, China
    2Beijing University of Chinese Medicine, Achievement Transformation Center, Beijing 100029, 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
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
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
Links
Articles
Latest Articles
Most Read
Collections
Updates
Events
News
Multimedia
About
About Us
Contact
No. 86 Xueyuan South Road, Haidian District, Beijing
100081
010-62662699(Operation and Technical Support)
qkjq@cast.org.cn

Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House