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Research on adaptive licensing pathway for new drug registration
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Li YANG, Yu-wen CHEN, Di WU, Yan-yi WEI, Zu-guang WANG
Chinese Journal of New Drugs | 2021, 30(17) : 1546 - 1553
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Chinese Journal of New Drugs | 2021, 30(17): 1546-1553
Research on adaptive licensing pathway for new drug registration
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Li YANG, Yu-wen CHEN, Di WU, Yan-yi WEI, Zu-guang WANG
Affiliations
  • College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2021-09-15
Outline
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Adaptive licensing (AL) is a prospectively planned, flexible approach for the regulation of drugs and biologics. AL is based on the stakeholder model of patients, health-care providers, payers, and regulators, seeking maximizing the positive impact of new drugs on public health by balancing timely access for patients with the need to assess and provide adequate evolving information on benefits and harms, so that better-informed patient-care decisions can be made. This paper reviews the emergence and development of AL, deeply analyzed the principles and design ideas of AL, and discussed the risk management and safeguard measures in AL. This paper will provide theoretical and practical reference for the construction of AL pathway in China.

new drug  /  registration  /  adaptive licensing  /  pathway
杨莉, 陈玉文, 吴迪, 韦彦伊, 王祖光. 新药注册适应性批准路径研究. 中国新药杂志, 2021 , 30 (17) : 1546 -1553 .
Li YANG, Yu-wen CHEN, Di WU, Yan-yi WEI, Zu-guang WANG. Research on adaptive licensing pathway for new drug registration[J]. Chinese Journal of New Drugs, 2021 , 30 (17) : 1546 -1553 .
Year 2021 volume 30 Issue 17
33
9
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  • Online Date:2026-10-28
  • Published:2021-09-15
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  • Accepted:2021-05-05
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    College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
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表12种不同金属材料的力学参数
科
Family
属数
Number of
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种数
Number of
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Number of
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Percentage of total
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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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