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Factors Influencing the Efficiency of Review and Approval of Innovative Drugs in China: An Industrial Perspective
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Xinyue LI1, 2, Jingwen HE1, 2, Yi WU1, 2, Ruichen MAO1, 2, Rong JIANG1, 2, *, Rong SHAO1, 2
Chinese Pharmaceutical Journal | 2025, 60(2) : 201 - 206
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Chinese Pharmaceutical Journal | 2025, 60(2): 201-206
Factors Influencing the Efficiency of Review and Approval of Innovative Drugs in China: An Industrial Perspective
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Xinyue LI1, 2, Jingwen HE1, 2, Yi WU1, 2, Ruichen MAO1, 2, Rong JIANG1, 2, *, Rong SHAO1, 2
Affiliations
  • 1 Institute of Regulatory Sciences, China Pharmaceutical University, Nanjing 211198, China
  • 2 NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing 211198, China
Published: 2025-01-22 doi: 10.11669/cpj.2025.02.014
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OBJECTIVE To identify the factors affecting the efficiency of the review and approval process of innovative drugs based on the industrial perspective to provide reference for further strengthening the capacity building and accelerating the review and approval of the marketing of innovative drugs. METHODS Using the grounded theory, this study conducted semi-structured interviews with 15 experts in the field of drug registration from March to May 2023, and Nvivo node coding was used as a traction to construct a model of factors influencing the efficiency of China's innovative drug marketing review and approval. RESULTS We have extracted 14 initial concepts, six initial areas and three main areas, i.e., “review and approval of institutional and team building”“accelerated assessment and approval policies” and “drug technological guidance system”. CONCLUSION The efficiency of review and approval of the marketing of innovative drugs in China is constrained by a variety of factors, and under the industrial perspective, accelerated assessment and approval policies, review and approval team building, and drug technological guidance system still need to be improved and optimized especially.

innovative drug  /  review  /  approval  /  grounded theory  /  influencing factor  /  NVivo
Xinyue LI, Jingwen HE, Yi WU, Ruichen MAO, Rong JIANG, Rong SHAO. Factors Influencing the Efficiency of Review and Approval of Innovative Drugs in China: An Industrial Perspective[J]. Chinese Pharmaceutical Journal, 2025 , 60 (2) : 201 -206 . DOI: 10.11669/cpj.2025.02.014
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Year 2025 volume 60 Issue 2
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doi: 10.11669/cpj.2025.02.014
  • Receive Date：2024-02-29
  • Online Date：2025-11-08
  • Published：2025-01-22
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  • Received：2024-02-29
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Affiliations
    1 Institute of Regulatory Sciences, China Pharmaceutical University, Nanjing 211198, China
    2 NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation, Nanjing 211198, China
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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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