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Pharmaceutical considerations on novel pharmaceutical preparations in China encourage generic drug catalogue (first to third batches)
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Xiao-fei SI, Gui-xia SUN, Bao-mei ZHANG, Tian-xing DAI, Yan-xiu GE, Dian-zhuo JIANG
Chinese Journal of Clinical Pharmacology | 2025, 41(1) : 143 - 148
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Chinese Journal of Clinical Pharmacology | 2025, 41(1): 143-148
• Drug Evaluation and Administration •
Pharmaceutical considerations on novel pharmaceutical preparations in China encourage generic drug catalogue (first to third batches)
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Xiao-fei SI, Gui-xia SUN, Bao-mei ZHANG, Tian-xing DAI, Yan-xiu GE, Dian-zhuo JIANG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
Published: 2025-01-17 doi: 10.13699/j.cnki.1001-6821.2025.01.029
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To meet the domestic clinical demand timely, the national health commission has released three batches of encourage generic drug catalogues, which plays a good guiding role in improving the supply level and accessibility of generic drugs. Based on literature investigation, the typical cases of novel pharmaceutical preparations were analyzed, and the pharmaceutical considerations were put forward in terms formulation, manufacturing process and quality control, aimed to provide scientific reference for research and development of such drugs.

China encourage generic drug catalogue  /  novel pharmaceutical preparation  /  formulation and manufacturing process development  /  quality control  /  generic drug
Xiao-fei SI, Gui-xia SUN, Bao-mei ZHANG, Tian-xing DAI, Yan-xiu GE, Dian-zhuo JIANG. Pharmaceutical considerations on novel pharmaceutical preparations in China encourage generic drug catalogue (first to third batches)[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (1) : 143 -148 . DOI: 10.13699/j.cnki.1001-6821.2025.01.029
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doi: 10.13699/j.cnki.1001-6821.2025.01.029
  • Receive Date：2024-03-30
  • Online Date：2026-08-04
  • Published：2025-01-17
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  • Received：2024-03-30
Affiliations
    Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
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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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