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2015-07-31 识林

7月31日FDA在联邦公报通告上宣布2016财年（2015年10月1日至2016年9月30日）GDUFA付费。新的收费与前几年收费(的比较列表如下。

将2013年总收费的2.99亿美元根据通货膨胀逐年调整，2016财年总收费为3.184亿美元。

由于2013财年2.99亿美元的收费中包括2013财年前2868件待批准申请缴纳的共5000万美元积压费，之后的财年收费不再包括积压费。为方便读者对比每财年实际根据申请数计算得出的各项设施费及申请费，将2013财年收费做了“标准化调整”，按刨除5000万积压费后的收费总数2.49亿美元计算各项收费，即每项“调整”为原来的1.2倍（2.99/2.49＝1.2）对于那些要交第四次GDUFA费的企业，让我们祈祷今年申请获批，结束缴费的长途跋涉吧！

API和FDF设施费保持在相对稳定，或许表明首次申报者添加的新设施与申请中不再引用的设施处于平衡状态。

最令人意外的是申请费用。DMF递交费增长了58%，在GDUFA计划前3年保持相对稳定后，一下子从26,720美元涨到42,170美元。ANDA递交费从58,730美元涨到76,030美元，增长30%。ANDA费被去年6月份赶在稳定性规则改变之前的大规模递交所影响，之后几个月的ANDA递交匮乏是可以理解的。然而，对于DMF费的变化就没有这么简单的解释了，似乎只是DMF的提交量减少。

作者：识林-Pepper
翻译：识林-椒
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GDUFA Fees for 2016 Announced
Dr. Pepper

FDA published a Federal Register Notice today (July 31, 2015) announcing GDUFA fees for Fiscal Year 2016 (October 1, 2015 to September 30, 2016). The new fees are tabulated below together with fees from prior years for comparison.

Inflation adjustment of the original total GDUFA annual fee collection of $299 million now brings the annual total for FY 2016 to $318.4 million.

The facility fees for both API and FDF facilities remain relatively constant perhaps indicating that new facilities being added by first time filers are in balance with facilities no longer referenced in applications.

The big surprise is application fees. The DMF Filing Fee has risen 58%, from $26,720 to $42,170 after being relatively stable for the first 3 years of the Program. The ANDA Filing Fee has risen almost 30% to $76,030 from $58,730. The ANDA fee has been effected by the huge number of filings in June of last year to beat the 3 batches rule coming in which was understandably followed by a dearth of ANDA filings in the following months. However there is no such simple explanation for the DMF fee change, it seems that there are just fewer DMFs being filed.

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