A cross-national comparative study of orphan drug policies in the United States, the European Union, and Japan: towards a made-in-China orphan drug policy.

Liu BC; He L; He G; He Y

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A cross-national comparative study of orphan drug policies in the United States, the European Union, and Japan: towards a made-in-China orphan drug policy.

机译：美国，欧洲联盟和日本对孤儿药政策的跨国比较研究：针对中国制造的孤儿药政策。

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Rare diseases can severely impact patient life quality as well as impose a serious burden on society. But research and development for drugs to treat these disorders has stagnated because of lack of demand, insufficient knowledge of pathophysiological mechanisms, and too few patients for clinical trials. In several countries--the United States, the EU, and Japan--specific legislation has been enacted to encourage pharmaceutical companies to expedite the development of drugs for rare diseases, orphan drugs, and to assure access to them. We analyze the strengths and weaknesses of the incentives in these laws and describe the status of rare diseases in China. We offer some recommendations for orphan drug legislation in China, based on local research on rare diseases.

机译：罕见疾病会严重影响患者的生活质量，并给社会带来沉重负担。但是由于缺乏需求，对病理生理机制的了解不足以及用于临床试验的患者太少，用于治疗这些疾病的药物的研究和开发一直停滞不前。在美国，欧盟和日本等几个国家，已经制定了专门的立法，以鼓励制药公司加快开发罕见病药物，孤儿药物并确保其获得。我们分析了这些法律中激励措施的优缺点，并描述了中国罕见病的状况。我们根据对稀有疾病的本地研究为中国的孤儿药立法提供一些建议。

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《Journal of public health policy》 |2010年第4期|共14页
作者
Liu BC; He L; He G; He Y;
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正文语种 eng
中图分类预防医学、卫生学;
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1. A cross-national comparative study of orphan drug policies in the United States, the European Union, and Japan: towards a made-in-China orphan drug policy. [J] . Liu BC, He L, He G, Journal of public health policy . 2010,第4期

机译：美国，欧洲联盟和日本对孤儿药政策的跨国比较研究：针对中国制造的孤儿药政策。
2. Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan, Non‐oncology Drugs in the European Union and United States from 2012?2016 [J] . Morant Anne Vinther, Jagalski Vivien, Vestergaard Henrik Tang Clinical and translational science. . 2019,第4期

机译：从2012年起支持欧盟和美国新非孤儿，非肿瘤学毒品的单关节试验的特征？2016年
3. Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans [J] . Hirota Saeko, Yamaguchi Takuhiro Pharmacoepidemiology and drug safety . 2018,第11期

机译：区分重要潜在风险的重要潜在风险的因素：日本安全规范的分析及欧盟风险管理计划
4. Message Passing on Factor Graph: A Novel Approach for Orphan Drug Physician Targeting [C] . Yunlong Wang, Yong Cai International conference on data mining . 2017

机译：信息传递到因子图上：靶向孤儿药物医师的新方法
5. Quasi-experimental study to determine the impact of parallel trade and external reference pricing strategies utilized by the European Union (EU) on the rate of drug approval launches and patient access to U.S. designated fast track drugs and orphan drugs. [D] . King, Josephine G. 2008

机译：一项准实验研究，旨在确定欧盟（EU）使用的平行贸易和外部参考定价策略对药物批准投放率和患者使用美国指定的快速通道药物和孤儿药物的速度的影响。
6. Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan Non‐oncology Drugs in the European Union and United States from 2012−2016 [O] . Anne Vinther Morant, Vivien Jagalski, Henrik Tang Vestergaard 2019

机译：2012-2016年间支持欧盟和美国新型非孤儿非肿瘤药物新法规批准的单项关键试验的特征
7. PHP39 The “Weight” of Orphan Drugs in the European Pharmaceutical Policy. A Focus on the Expenditure and the Utilization of Orphan Drugs in Five European Union Countries [O] . Muscolo L.A.A., Deriu D., Sammarco A., 2012

机译：PHP39欧洲药品政策中孤儿药的“重量”。着重于五个欧盟国家的孤儿药品支出和利用

A cross-national comparative study of orphan drug policies in the United States, the European Union, and Japan: towards a made-in-China orphan drug policy.

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