2010-2015年美国FDA批准上市的孤儿药研究
发布时间：2018-11-08 07:06
【摘要】：目的:了解2010-2015年美国FDA批准的孤儿药的情况,为我国孤儿药的相关立法和新药研发提供参考。方法:查阅近年来国内外相关文献,对2010-2015年美国FDA批准的孤儿药进行统计和分析。结果与结论:2010-2015年美国FDA批准上市的孤儿药共77种,仅2015年就有21种,占该年获批新药的46.67%。获批孤儿药主要是治疗肿瘤、内分泌及代谢系统疾病、心血管疾病、感染性疾病、神经及精神疾病和血液系统疾病等全球高发疾病的药物,其中以抗肿瘤药物为主(38种,占49.35%),主要用于治疗黑色素瘤、非小细胞肺癌和白血病。美国FDA批准的孤儿药的研发企业以美国为主。我国尚无明确的罕见病和孤儿药的定义及相关立法,亟需加快相关立法进程,结合国情开展孤儿药的研发与审批。
[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.
【作者单位】： 昆明市延安医院药学部;
【分类号】：R95
[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.
【作者单位】： 昆明市延安医院药学部;
【分类号】：R95
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