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Analysis on orphan drug security policy from the perspective of drug life cycle in China
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Ni YUAN1, 2, Na ZHOU2, Hai-jun ZHANG3, Zheng LI2, Xu ZHANG2, Yong WANG1
Chinese Journal of New Drugs | 2021, 30(1) : 1 - 5
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Chinese Journal of New Drugs | 2021, 30(1): 1-5
Analysis on orphan drug security policy from the perspective of drug life cycle in China
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Ni YUAN1, 2, Na ZHOU2, Hai-jun ZHANG3, Zheng LI2, Xu ZHANG2, Yong WANG1
Affiliations
  • 1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
  • 2School of Public Health, Dalian Medical University, Dalian 116044, China
  • 3School of Public Health, Peking University, Beijing 100191, China
Published: 2021-01-15
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By combing the relevant policies of national and local orphan drug security policy, this paper analyzed the current situation of orphan drug security policy in China from the perspective of drug life cycle, and puted forward corresponding countermeasures and suggestions. In this paper, by consulting the relevant literature, searching the national and local government websites and the network platforms of rare disease-related organizations, combed the policies in the stages of drug research and development, registration, pricing and reimbursement, supply, post-market supervision (drug vigilance) and diagnosis and treatment of rare diseases from 2015 to 2020. In the past five years, the state and various ministries have issued a series of orphan drug protection policies, as well as some provinces and cities issued some orphan drug reimbursement policies, but there is no search for China's special post-market supervision policy for orphan drugs. It is suggested that under the premise of multi-sector cooperation, our country can set up full-time departments for rare diseases and orphan drug protection to provide diversified protection measures for patients with rare diseases.

orphan drug  /  drug life cycle  /  security policy
袁妮, 周娜, 张海军, 李铮, 张旭, 王勇. 药品全生命周期视角下中国罕见病药物保障政策简析. 中国新药杂志, 2021 , 30 (1) : 1 -5 .
Ni YUAN, Na ZHOU, Hai-jun ZHANG, Zheng LI, Xu ZHANG, Yong WANG. Analysis on orphan drug security policy from the perspective of drug life cycle in China[J]. Chinese Journal of New Drugs, 2021 , 30 (1) : 1 -5 .
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Year 2021 volume 30 Issue 1
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  • Online Date：2026-10-29
  • Published：2021-01-15
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  • Accepted：2020-10-05
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Affiliations
    1School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing 211198, China
    2School of Public Health, Dalian Medical University, Dalian 116044, China
    3School of Public Health, Peking University, Beijing 100191, 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
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
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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