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Technical requirements for allergen products registration regulated as drug management
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Yan-hua JIA, Ying ZHANG, Min LI
Chinese Journal of New Drugs | 2023, 32(24) : 2513 - 2516
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Chinese Journal of New Drugs | 2023, 32(24): 2513-2516
Technical requirements for allergen products registration regulated as drug management
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Yan-hua JIA, Ying ZHANG, Min LI
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2023-12-30
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Allergic diseases are recognized by the World Health Organization (WHO) as a major health problem in the world. At present, allergen products have been widely used in the treatment of various allergic diseases at home and abroad. Allergen therapy is currently the only therapy that can regulate the immune system in patients with allergic rhinitis. However, high quality allergen products are related to the effectiveness of the products. In view of the important clinical value of allergen products, combined with the status quo of listed allergen products and registered allergen products, this paper briefly introduces the registration management classification of allergen products in China and the United States and the technical requirements for the registration of such products in China.

allergen  /  drug  /  registration
Yan-hua JIA, Ying ZHANG, Min LI. Technical requirements for allergen products registration regulated as drug management[J]. Chinese Journal of New Drugs, 2023 , 32 (24) : 2513 -2516 .
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:2023-11-06
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
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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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