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美国上市的480种罕见病药物中中国占比38。33%，欧盟上市的115种罕见病药物中中国占比29。57%。《第一批罕见病目录》中的36种疾病有获美国FDA批准的罕见病药物60种，中国上市药物占比43。33%；18种疾病有获欧盟EMA批准的罕见病药物27种，中国占比29。63%。中国上市的针对《第一批罕见病目录》的27种罕见病药物中51。85%完全依赖进口。我国罕见病药物上市情况与国际发达国家和地区相比仍有一定差距，应加快罕见病药物的研发、仿制，提高我国罕见病药物的保障水平。
<<China had 38.33% of 480 orphan drugs commercially available in US，and 29.57% of 115 orphan drugs commercially available in EU. For the 36 diseases listed in the Directory of First Batch of Rare Diseases，60 orphan drugs have been approved by the US FDA，and 43.33% of which are commercially available in China；For 18 diseases among it，27 orphan drugs have been approved by the EU EMA，and 29.63% of which are commercially available in China. 51.85% of the 27 orphan drugs listed in the Directory of First Batch of Rare Diseases are completely dependent on imports. There is still a certain gap in the commercial availability of orphan drugs between China and the developed countries and regions in the world. It is necessary to speed up the research and imitation of rare diseases and improve the level in guaranteeing orphan drugs in China.
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