【摘要】：目的:了解2010-2015年美國(guó)FDA批準(zhǔn)的孤兒藥的情況,為我國(guó)孤兒藥的相關(guān)立法和新藥研發(fā)提供參考。方法:查閱近年來(lái)國(guó)內(nèi)外相關(guān)文獻(xiàn),對(duì)2010-2015年美國(guó)FDA批準(zhǔn)的孤兒藥進(jìn)行統(tǒng)計(jì)和分析。結(jié)果與結(jié)論:2010-2015年美國(guó)FDA批準(zhǔn)上市的孤兒藥共77種,僅2015年就有21種,占該年獲批新藥的46.67%。獲批孤兒藥主要是治療腫瘤、內(nèi)分泌及代謝系統(tǒng)疾病、心血管疾病、感染性疾病、神經(jīng)及精神疾病和血液系統(tǒng)疾病等全球高發(fā)疾病的藥物,其中以抗腫瘤藥物為主(38種,占49.35%),主要用于治療黑色素瘤、非小細(xì)胞肺癌和白血病。美國(guó)FDA批準(zhǔn)的孤兒藥的研發(fā)企業(yè)以美國(guó)為主。我國(guó)尚無(wú)明確的罕見(jiàn)病和孤兒藥的定義及相關(guān)立法,亟需加快相關(guān)立法進(jìn)程,結(jié)合國(guó)情開(kāi)展孤兒藥的研發(fā)與審批。
[Abstract]:Aim: to investigate the status of orphan drugs approved by FDA in the United States from 2010 to 2015, and to provide references for the legislation of orphan drugs and the research and development of new drugs in China. Methods: to review the related literature in recent years and analyze the orphan drugs approved by FDA of the United States from 2010 to 2015. Results & conclusion: there were 77 kinds of orphan drugs approved by FDA in the United States from 2010 to 2015, and 21 kinds in 2015 alone, accounting for 46.67% of the new drugs approved in that year. The approved orphan drugs are mainly used to treat cancer, endocrine and metabolic system diseases, cardiovascular diseases, infectious diseases, neurological and mental diseases and blood system diseases, among which 38 are anti-tumor drugs. (49.35%), mainly used in the treatment of melanoma, non-small cell lung cancer and leukemia. FDA approved by the United States Orphan Drug R & D enterprises mainly in the United States. There is no clear definition and legislation of rare diseases and orphan drugs in China. It is urgent to speed up the process of legislation and carry out the research and approval of orphan drugs according to the national conditions.
【作者單位】： 昆明市延安醫(yī)院藥學(xué)部;
【分類(lèi)號(hào)】：R95

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