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各国孤儿药政策对比分析
引用本文:毛元圣.各国孤儿药政策对比分析[J].微生物学杂志,2016(6).
作者姓名:毛元圣
作者单位:1. 美中医药开发协会,纽约州 纳纽埃特,10954;2. 美国汉佛莱医药顾问有限公司,马里兰州 贝塞斯达,20817
摘    要:据统计,医学上明确诊断的罕见病有5 000~8 000 种。虽然因患病人数少而得名罕见病,但考虑到疾病种类之多,罕见病仍是 各国不可忽视的公共卫生挑战。协助和激励医疗行业开发治疗罕见病的孤儿药,是各国政府一项重要的公共卫生政策。重点介绍了美国、 日本和欧盟的孤儿药立法,激励政策以及对病患、医药行业的积极影响。

关 键 词:罕见病  孤儿药  公共卫生政策  新药开发  政府激励

Comparative Study on Orphan Drug Policies of US, Japan and Europe
MAO Yuansheng.Comparative Study on Orphan Drug Policies of US, Japan and Europe[J].Journal of Microbiology,2016(6).
Authors:MAO Yuansheng
Institution:1. Sino-American Pharmaceutical Professionals Association, Nanuet 10954, America; 2.Humphries Pharmaceutical Consulting, Bethesda 20817, America
Abstract:According to statistics, 5 000 to 8 000 rare diseases have been clearly diagnosed by modern medicine. Although rare disease is characterized by small patient population, it is still a challenge to public health if considering the total number of rare diseases. Governments consider assisting and encouraging healthcare industry to develop orphan drugs as an important public health policy. This article introduces current orphan drug legislation and incentive policies in the US, Japan and Europe as well as their optimistic impact on patients and healthcare industry.
Keywords:orphan drug  rare disease  public health policy  new drug development  government incentive
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