近年来美国FDA批准上市药品分析

摘要

目的：分析近年来FDA批准上市的药品，为我国药品的研发和审批提供借鉴。方法通过查阅文献，分析美国上市药品的数量变化、重点治疗领域和审评时限变化。结果与结论近年来FDA批准上市的药品数量呈增加趋势，对孤儿药、儿科药、肿瘤疾病、神经及精神疾病等治疗领域重视度增加，审评时限逐渐缩短。我国可以参考美国FDA批准上市的药品，改进药品审批政策，从而促进创新药和仿制药的发展。%Objective To analyze drugs approved by FDA in recent years, and provide references for developing and approving drugs in China. Methods This article analyzes the number, review timeline and therapeutic area of drugs approved in America by literature. Results and Conclusion The number of drugs approved by FDA has increased recently, the review timeline is shortened, and they have improved their focus on orphan drug, pediatric drug, cancer area, neurological and psychiatric disease and so on. Our country can refer to the drugs FDA has approved, and improve the policies of drugs approving to facilitate the development of new drugs and generic drugs.