收藏切换
Analysis and discussion of generic drug consistency evaluation in NMPA and relevant drug policies in FDA and PMDA
收藏切换
Dong LI, Hong-jin DU, Yu ZHOU, Dong LIU, Yi-lin LIU, Li-li HA, Fang LI, Jin-bo YANG
Chinese Journal of New Drugs | 2021, 30(13) : 1164 - 1167
Less
收藏切换
Chinese Journal of New Drugs | 2021, 30(13): 1164-1167
Analysis and discussion of generic drug consistency evaluation in NMPA and relevant drug policies in FDA and PMDA
Full
Dong LI, Hong-jin DU, Yu ZHOU, Dong LIU, Yi-lin LIU, Li-li HA, Fang LI, Jin-bo YANG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2021-07-15
Outline
收藏切换

Generic drug has made a large contribution to our medical security system; however, the pharmaceutical industry starts late in China and there still exists a wide gap between generic drugs and original drugs. Given this situation, the generic drug consistency evaluation is extremely meaningful to ensure the efficacy and safety of generic drugs, and it is impressive for improving the integral level of pharmaceutical industry. This article discusses the relevant policies of the generic drug consistency evaluation in China, such as ensuring the consistency between generic drugs and original drugs, establishment of the strict review and supervision system, etc. At the same time, this article also outlines the relevant drug policies and their development process in US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA). We expect that the comparison and analysis would be benefit to the generic drug consistency evaluation in our country.

generic drug  /  generic drug consistency evaluation  /  drug efficacy study implementation  /  quality reevaluation
李栋, 杜宏金, 周誉, 刘冬, 刘意林, 哈莉莉, 李芳, 杨进波. 中国仿制药一致性评价政策与美国、日本相关政策的分析与讨论. 中国新药杂志, 2021 , 30 (13) : 1164 -1167 .
Dong LI, Hong-jin DU, Yu ZHOU, Dong LIU, Yi-lin LIU, Li-li HA, Fang LI, Jin-bo YANG. Analysis and discussion of generic drug consistency evaluation in NMPA and relevant drug policies in FDA and PMDA[J]. Chinese Journal of New Drugs, 2021 , 30 (13) : 1164 -1167 .
Year 2021 volume 30 Issue 13
31
4
Cite this Article
BibTeX
Article Info
  • Online Date:2026-10-30
  • Published:2021-07-15
Article Data
Affiliations
History
  • Accepted:2020-10-15
Funding
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
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