国外孤儿药现状分析及对我国的启示

发布时间：2018-05-03 19:53

本文选题：孤儿药 + 现状分析　；参考：《中国医药工业杂志》2015年10期

【摘要】：目前,孤儿药的研发受到越来越多的关注。全球范围内获得指定或批准上市的孤儿药数量不断增多,但在鼓励孤儿药研发和生产的同时,更应系统考虑罕见病患者的用药可及性。本研究意在探究影响孤儿药可及性的关键因素,为我国罕见病及孤儿药的发展提供参考。通过分析国外孤儿药现状,探究影响孤儿药可及性的因素,综合分析了他国经验以为我国孤儿药研发提供建议。结果显示,国外相关立法及政策制定极大促进了孤儿药的研发与生产,但为了真正提高罕见病患者的用药可及性,成本控制也是关键。我国应加快建立孤儿药政策,并从多方面着手进行成本控制,以加快促进药物的研发,提高用药可及性,缓解用药压力。
[Abstract]:At present, the research and development of orphan medicine is receiving more and more attention. The number of orphan drugs that have been designated or approved for the market is increasing in the world, but while encouraging the development and production of orphan drugs, the availability of drugs for patients with rare diseases should be taken into account systematically. The purpose of this study is to explore the key factors affecting the availability of orphan drugs and to provide references for the development of rare diseases and orphan drugs in China. By analyzing the current situation of orphan drugs in foreign countries and exploring the factors that affect the availability of orphan drugs, the experiences of other countries are analyzed synthetically to provide suggestions for the development of orphan drugs in China. The results showed that foreign legislation and policy formulation greatly promoted the development and production of orphan drugs, but in order to truly improve the drug availability of patients with rare diseases, cost control is also the key. China should speed up the establishment of orphan drug policy and carry out cost control from many aspects in order to accelerate the development of drugs improve the availability of drugs and relieve the pressure of drug use.
【作者单位】：沈阳药科大学工商管理学院;
【分类号】：R95

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