摘要：目的：分析我国孤儿药目前存在的问题，为我国医药行业同行和监管机构建立孤儿药管理制度提供借鉴与参考。方法：通过专业数据库与相关网站的查询，借鉴国外及我国台湾地区关于孤儿药发展的立法经验，分析我国目前孤儿药的问题。结果与结论：建议相关管理机构从明确孤儿药定义、以优惠政策促进孤儿药的研发、建立合理的支付机制、提高公众对孤儿药的认识方面入手，尽早完善我国孤儿药的管理体制和制度。

    关键词：孤儿药；罕见病；问题；建议

    Discussion on Several Issues of Our Orphan Drugs

    Meng Rui Xu Qi Han Xiaoliang et al.

    Abstract:Objective:Analysis of existing problems of China’s orphan drug orphan drug management system for China’s pharmaceutical industry peers and regulatory agencies to provide references.Methods:Query specialized databases and related web sites, drawing on the legislative experience of foreign countries and Taiwan region of China on the development of orphan drugs, the analysis of the orphan drugs. Results & Conclusions:Suggested that the relevant management agencies from the definition of clear orphan drugs and preferential policies to promote the development of orphan drugs, establish a reasonable payment mechanisms, to raise public awareness of the orphan drugs starting as early as possible to improve the management structure and system of orphan drugs. ......