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Thoughts on the characteristics of priority review and approval of rare disease drugs in China
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Qian-nan CHEN1, Xiao-xi LIU1, Gui-yu LIAN1, 2, *, Zhe HUANG1, 2, *
Chinese Journal of New Drugs | 2026, 35(13) : 1352 - 1357
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Chinese Journal of New Drugs | 2026, 35(13): 1352-1357
Thoughts on the characteristics of priority review and approval of rare disease drugs in China
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Qian-nan CHEN1, Xiao-xi LIU1, Gui-yu LIAN1, 2, *, Zhe HUANG1, 2, *
Affiliations
  • 1Collegel of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2026-07-15 doi: 10.20251/j.cnki.1003-3734.2026.13.002
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Objective:

To analyze the characteristics of rare disease drugs approved through the priority review and approval process in China from 2018 to 2024, and to provide a reference for optimizing review policies for rare disease drugs and improving drug access.

Methods:

Based on data from the National Medical Products Administration and Yaozh Data (Drug Intelligence Data) and other sources, a descriptive statistical analysis was conducted on the main features of rare disease drugs approved through priority review and approval.

Results:

A total of 86 rare disease drugs were included in this study from 2018 to 2024, with an average review and approval duration of 463.55 days. Among them, chemical drugs accounted for 58%, imported drugs accounted for 77.9%, and domestic drugs only accounted for 22.1%. A total of 44 drugs were included in the national medical insurance catalog, and only 4 were pediatric-specific.

Conclusion:

China has established a multi-pathway accelerated approval system for rare disease drugs, significantly improving the accessibility of rare disease drugs. However, there are still issues such as insufficient supply of domestic innovative drugs, uneven coverage of therapeutic areas, and a shortage of pediatric drugs.

rare disease drugs  /  priority review and approval  /  characteristics of drug marketing  /  orphan drugs
陈倩楠, 刘晓溪, 连桂玉, 黄哲. 对我国优先审评审批罕见病用药特征的思考. 中国新药杂志, 2026 , 35 (13) : 1352 -1357 . DOI: 10.20251/j.cnki.1003-3734.2026.13.002
Qian-nan CHEN, Xiao-xi LIU, Gui-yu LIAN, Zhe HUANG. Thoughts on the characteristics of priority review and approval of rare disease drugs in China[J]. Chinese Journal of New Drugs, 2026 , 35 (13) : 1352 -1357 . DOI: 10.20251/j.cnki.1003-3734.2026.13.002
Appendix
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Year 2026 volume 35 Issue 13
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.13.002
  • Online Date：2026-10-26
  • Published：2026-07-15
Article Data
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History
  • Accepted：2026-02-25
Funding
Affiliations
    1Collegel of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
    2Research Institute of Drug Regulatory Science, Shenyang Pharmaceutical University, Shenyang 110016, China
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https://castjournals.cast.org.cn/joweb/zgxyzz/EN/10.20251/j.cnki.1003-3734.2026.13.002
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表12种不同金属材料的力学参数
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Family		 属数
Number of
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Number of
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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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