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China Orphan Drug Update 2017

China currently has virtually no specific policies or legislation regarding orphan drugs despite having 16.8 million patients with rare diseases, according to the Chinese Center for Disease Control and Prevention. Furthermore, many orphan drugs approved in western countries are unavailable in China.... Read More

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Japan Orphan Drug Update 2017

Introduction Japan has some of the highest healthcare standards in the world, with the Japanese government providing health insurance for approximately 99% of its citizens. After the United States, Japan was the second country to establish regulations for the development of orphan... Read More

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日本扩大孤儿药的指定标准

2015年4月1日,日本厚生劳动省(MHLW)宣布了更新后的孤儿药认定标准。这一新规定可能也会应用到孤儿医疗器械的认定体系。 用于治疗“指定的难治性疾病”的药物现在有资格被认定为孤儿药。现在定义为影响日本人 口约0.1%的疾病 — 政府还澄清在日本患者人群最多不超过18万将被视为符合条 件。在此之前,用于治疗50,000或更少的患者的疾病才可以被认定为孤儿药。 这一改变意味着更多的治疗将有机会在日本被认定为孤儿药。这包括溃疡性结肠炎,一种影响大概144,000日本患者的疾病,帕金森病,影响约110,000日本患者。 除了改变患者的人口标准,其他孤儿药的认定标准保持不变。日本为研发孤儿药的公司提供多种奖励措施,如优惠的税收待遇、药品补贴款,以及注册申请时的优先审评。 Read More