罕见病当前国际政策及现状介绍

Introduction of Current International Policies and Situation of the Rare Diseases

目的：为我国罕见病医疗保障和用药法规的建立提供借鉴和参考。方法：介绍和分析不同国家和地区对罕见病及其药物开发的政策。结果：各主要发达国家在药品注册方面和管理方面都有一套相关政策．包括对孤儿药的认定及其开发研究的鼓励政策，值得我国在孤儿药品注册和药品管理政策制定时借鉴和参考。结论：明确罕见病的定义．制定激励措施对罕见病的研究进展有很大的推动作用。

Objective： To provide the reference for establishing the policy of rare disease and orphan drugs in China. Methods： Analyzing incentive measures for the development of orphan drugs in different countries and regions. Results： The major developed countries have a set of related policies in the medical registration and management aspects, including the identification of orphan drugs and its development policy, it is worth of learning.Conclusions： Definiting the rare diseases and making incentive measures can encourage the research and development of rare diseases.