Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
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
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
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
On April 1, 2015, Japan’s Ministry of Health, Labor and Welfare (MHLW) notified stakeholders of an updated criterion for orphan drug designation. This change will likely apply to the orphan medical device designation system as well. Drugs that treat “designated intractable diseases”... Read More
This Japan drug regulatory PowerPoint presentation covers many basic issues for international drug companies looking to gain more knowledge about the Japanese drug market. It includes information on registering ethical, biological, orphan, and generic drugs in Japan. The presentation also provides information... Read More
In Japan, pharmaceutical products can be given orphan drug designation by the Ministry of Health, Labor and Welfare (MHLW). A high medical need must exist for the product, and there must be no available alternative treatment. The drug must also be safe... Read More
在日本，孤儿药的认定需要通过日本健康，劳动和福利部（MHLW）部。大量的医疗需求要求开发医疗产品，特别是没有可用的替代疗法的疾患。孤儿药的定义是指对于病患数低于50,000安全和有效的药物。然而，孤儿药的指定并不意味着它会自动给予药物的销售许可。 Read More
Medical experts estimate that about 10 million Chinese patients have some type of rare disease. Specific legislation on orphan drugs is still lacking in China. However, since 2009, a fast approval process for drugs related to some rare diseases has been in... Read More
医学专家估计，大约有1000万中国患者有某种类型的罕见疾病。然而在中国对研发治疗罕见疾病的药物尚未进行立法。然而，自2009年起，某些治疗罕见疾病的药物被纳入快速审批流程。药品法中有对于研发治疗罕见疾病药物获得减低临床试验的要求的规定。 Read More