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2014-11-04 Lachman CONSULTANTS

随着月初几天批准的乏力（直到14年10月26日仅批准了3件ANDA），仿制药办公室（OGD）在本月最后几天批准进入高潮，至本月结束前总共批准31件ANDA。

行动开始于10月27日（顺便提一句，是GPhA秋季技术研讨的第一天），记录显示一天之内批准的了9件ANDA，然后10月28日批准了6件，10月29日批准5件，10月30日批准8件。4天时间内平均每天批准7件ANDA — 以这样的速度，推到整个月，意味着每月批准超过130件ANDA。现在这将真的让企业感到高兴。我不认为我们可以期待持续每天批准这个数量，但是很高兴在10月底看到这个小高潮。

根据《2012仿制药使用者付费法案》，对前两年的申请没有绩效指标要求，从第3年开始开始有指标要求，第3队列年（2015财年）需要对60%的提交采取行动，到第5年队列年需要在10个月内对90%的提交采取行动。随着第3队列年和相关的指标拉开帷幕，如果OGD可以达到每月批准70件ANDA的水平（过去的2014财年平均批准速度为每月34件），企业将会很高兴。OGD背后基础设施、人员配备、培训和程序等已到位并开始比预想和猜测的更快的速度大量着手批准和其它行动。这可能是事实，但一个月中的4天并不能形成趋势！

企业的目光都集中在了重要的事情上，随着2014财年的409件批准，企业显然希望2015财年的批准数据会显著提高。接下来的几个月将成为这种变化的重要晴雨表。

Lachman CONSULTANTS - Bob Pollock先生 2014-11-03
编译：识林-椒 2014-11-04

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OGD Puts the Pedal to the Metal the Last 4 Days of October to Reach 31 Approvals
Written by Bob Pollock • November 03, 2014

With an anemic start to the month (only 3 ANDA approvals through 10/26/14), the Office of Generic Drugs (OGD) kicked it into high gear during the last days of the month to end the month with 31 total final ANDA approvals.

The action began on 10/27 (the first day of the GPhA Fall Technical Workshop, incidentally) with a record one day approval of 9 ANDAs, then 6 on the 10/28, 5 on 10/29 and 8 on the 10/30. That 4 day span saw an average of 7 ANDAs approved a day – at that pace, extrapolated to a full month, that could mean >130 or more ANDA approved a month. Now THAT would really make the industry happy. I don't think that we can expect that volume of daily approvals to continue, but it is nice to see the spurt at the end of October.

With the beginning of cohort year 3 and of its associated metrics, if OGD could level out at about 70 ANDA approvals a month, I think that industry will be happy. The indications that OGD's behind-the-scenes work on infrastructure, staffing, training and procedures has placed the program in a position to start churning out approvals and other actions at a faster clip may be more than hope and conjecture and may indeed be fact. But- four days in one month does not a trend make!

The eyes of the industry are on the things that matter, and with 409 approvals in FY 201,4 industry is clearly hoping that the FY 2015 approval figures will be significantly higher. The next few months will serve as an important barometer for that change.