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Introduction to selection and management of reference listed drug for chemical generic drugs in China
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Zhuo-cheng ZHANG1, 2, Fang LI2, Na AN2, Jia-sheng TU1, Chun-meng SUN1, Li-li NING2
Chinese Journal of New Drugs | 2023, 32(5) : 476 - 480
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Chinese Journal of New Drugs | 2023, 32(5): 476-480
Introduction to selection and management of reference listed drug for chemical generic drugs in China
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Zhuo-cheng ZHANG1, 2, Fang LI2, Na AN2, Jia-sheng TU1, Chun-meng SUN1, Li-li NING2
Affiliations
  • 1National Medical Products Administration Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
  • 2Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
Published: 2023-03-15
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Reference listed drug, as the benchmark of generic drugs, is the reference drug for the consistency evaluation of quality and efficacy of a generic drug. As the starting point of developing a generic drug, reference listed drug selection is of great significance in the whole process of research and development. This paper comprehensively reviews the policy requirements of reference listed drug selection, and compares the regulation patterns on reference listed drug in China and the United States. Moreover, the common issues on those refused reference listed drug applications are summarized, and the reasons on reference listed drug alteration are analyzed. Consequently, it is expected that the principles and approaches of reference listed drug selection would be further clarified for the reference of the applicants.

chemical generic drugs  /  reference listed drug  /  consistency evaluation
Zhuo-cheng ZHANG, Fang LI, Na AN, Jia-sheng TU, Chun-meng SUN, Li-li NING. Introduction to selection and management of reference listed drug for chemical generic drugs in China[J]. Chinese Journal of New Drugs, 2023 , 32 (5) : 476 -480 .
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  • Online Date：2026-03-05
  • Published：2023-03-15
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History
  • Accepted：2022-09-26
Affiliations
    1National Medical Products Administration Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients, Department of Pharmaceutics, School of Pharmacy, China Pharmaceutical University, Nanjing 210009, China
    2Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, 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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