孤儿药激励政策国际比较分析与启示

发布时间：2018-01-26 16:22

本文关键词： 罕见病孤儿药激励政策新药研发上市　出处：《中国新药杂志》2015年06期 　论文类型：期刊论文

【摘要】：借鉴部分国家和地区孤儿药激励政策的实践经验,探求促进我国孤儿药研发上市的政策出路。对美国、日本、欧盟、澳大利亚、中国台湾等国及地区所采取的孤儿药激励政策进行研究和对比,并对我国罕见病及孤儿药领域现状及问题进行分析。国际上通过出台研发、注册和上市后等阶段的激励政策,从不同层面鼓励孤儿药的研发上市;我国缺乏相关的法律法规和鼓励性政策,社会各界对孤儿药的认知程度处于较低水平。我国有关部门应借鉴先进经验,建立适用于我国的孤儿药激励政策体系,如扶植大型企业研发孤儿药,并给予研发资助、税收减免等鼓励措施。
[Abstract]:Based on the practical experience of some countries and regions, this paper explores the policy way to promote the development and marketing of orphan drugs in China. For the United States, Japan, the European Union, Australia. This paper studies and compares the incentive policies of orphan drugs adopted by Taiwan and other countries and regions in China, and analyzes the current situation and problems in the field of rare diseases and orphan drugs in China. The incentive policies in the registration and post-marketing stages to encourage the development and marketing of orphan drugs from different levels; Our country lacks relevant laws, regulations and encouraging policies, and the level of cognition of orphan drugs is at a low level. The relevant departments of our country should draw lessons from advanced experience and establish an incentive policy system for orphan drugs that is suitable for our country. Such as support large enterprises to develop orphan drugs, and give R & D funding, tax relief and other incentives.
【作者单位】：北京大学药学院;北京大学医药管理国际研究中心;
【分类号】：R95
【正文快照】： 2012年1月,国务院印发《国家药品安全“十二五”规划》中明确提出要“鼓励罕见病用药和儿童适宜剂型研发”[1],标志着罕见病治疗用药的新药研发问题正式纳入国家层面的规划。次年,原国家食品药品监管管理局发布《关于深化药品审评审批改革进一步鼓励创新的意见》中指出,对治疗

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