FDA公布2014财年仿制药企业付费修正案(GDUFA)付费标准

FDA Generic Drug User Fee Act(GDUFA) for fiscal year 2014

FDA公布2014财年仿制药企业付费细则。根据通货膨胀指数调整后,2014财年仿制药企业付费总额为$305 659 000,各项付费标准分别为:仿制药申请$63 860,批准前补充申请$31 930,主文件$31 460,美国境内制剂设施$220 152,美国境外制剂设施$235 152,美国境内原料药设施$34 515,美国境外原料药设施$49 515。由于部分仿制药企业退出,各项付费额比前一财年显著增加。预期后继财年付费将会继续增长,但对仿制药行业的发展的影响并不明了。

FDA has announced the inflation adjusted Generic Drug User Fee Act （GUDFA） for fiscal year 2014 as $ 305 659 000. The fees for the abbreviated new drug application, prior approval supplement, drug master file, active pharmaceutical ingredient and finished dosage form facilities fees were $ 63 860, $ 31 460, $ 31 460, $ 220 152 and $ 235 152 （domestic and foreign） , and $ 34 515 and $ 49 515 （domestic and foreign） , respec- tively. The fee escalation, due to the shrinking number of generic manufacturers, is expected to continue, and its impact to the generic industry is unclear.