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出自识林

2015-10-07 Lachman CONSULTANTS

随着2015年10月1日的到来，GDUFA踏入第4队列年。仿制药办公室（OGD）9月份批准61件ANDA，继续打破GDUFA月批准记录，高调结束2015财年。之前完全批准量最高的一个月是2015年8月，当月OGD公布58件批准。9月OGD还公布了13件暂时批准，总批准行动为74件。2015财年总完全批准量为492件，创下过去7年中批准量第二高记录。此前最高批准量的年份为2012财年，517件完全批准。

下表是过去7年的年度ANDA接收和批准量，让我们看看将走向何方。

数据显示，2015财年接收量仅比批准量多17件。这意味着绝对积压只可能有不超过17件的增长。随着一些较旧申请的撤销（和可能地放弃），今年可能收支平衡。最引人注目的数字是，第3队列年（2015财年）仅递交509件ANDA。这个数字显著的比以往现代历史上的任何一年都低。是因为过去几年发生的许多兼并和收购（M&A）吗？因为M&A使得许多公司不得不放弃某些申请吗，对于收购公司来说获批的的资产比自己提交的申请更有吸引力？是因为专利悬崖？是因为监管和稳定性要求的增加？这种现象似乎没有单一的答案，但可以肯定的是，原始ANDA递交的下降使得OGD稍微松了口气。

较低的递交率更容易达到GDUFA目标（2015年10月1日生效），因此，过剩的审评资源将更可能用来审评没有GDUFA目标的“积压”以及第1队列年和第2队列年的申请。有迹象表明可以看到适用于第3队列年之前的ANDA的完全回应函（CRL）的一些指标，这真是太好了！

OGD继续与沟通交流做斗争，但最近的一次会议上，一些与会者指出，即使在与OGD的互动方面也有着显著改善。我们已经看到了一些重要的目标行动日期（TAD）的分配，这对于业界需要做出合理的商业决定的人们是个好消息。我们还听到流传着更多有关ANDA审评形势的好消息。

我们一直在预测，OGD正渡过难关。我们已经在这两天的FDA/PQRI会议上看到了许多FDA的新面孔，对于业界来说这是了解600名FDA新雇员中都有哪些人的好机会！OGD，干的好，继续保持吧！

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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Final Numbers in for ANDA Receipts and Approvals for FY 2015
By Bob Pollock | October 6, 2015

With October 1, 2015 signaling the start of cohort year 4 of the GDUFA program, the receipt and approval numbers are in the book for first three years of the program.

Let's take a look at the numbers to see where we may be heading.

FY 2015 showed just 17 more receipts than approvals. This means that the absolute backlog only could have grown by no more than 17 applications. With some withdrawals (and potentially abandonment) of some older applications, perhaps we may be at a wash for the year. The most striking figure is that only 509 ANDAs were submitted in cohort year 3 (FY 2015). This figure is substantially lower than any year in modern-day history. Could this be because of the many mergers and acquisitions (M&A) that have taken place over the last few years? Is it because of the M&As that many firms had to divest certain of their applications, thus making it more attractive for another firm to purchase the approved asset rather than submit its own application for the product? Is it because of the patent cliff? Is it because of the increase in regulatory and stability requirements? There is likely not one single answer to this phenomena, but I am certain that this drop in original ANDA submissions is making the Office of Generic Drugs (OGD) breathe a little easier.

Lower submission rates make it easier to meet the GDUFA goals (which kicked in on October 1, 2015), and thus, it follows that excess resources will likely be available to review the ”backlog” and cohort year 1 and cohort year 2 applications that did not have GDUFA goals. There are hints of some metrics to be applied to Complete Response Letter (CRL) responses for pre-cohort year 3 ANDAs. Wouldn’t that be nice!

OGD continues to struggle with communications, but at a recent meeting, some of the attendees actually noted that even this aspect of interactions with OGD is noticeably improving. We have seen a significant number of Target Action Dates (TADs) being assigned and that is good news for industry folks that need to make reasonable business decisions. We have also heard that more information is flowing about the status of the ANDA reviews – also a good sign.

We have been predicting that OGD was about to turn the corner and now it looks like their head may be peeking around the edge of the building. Maybe we will even see more FDA faces at the GPhA Fall Technical Workshop, as this is a great way for industry to learn who some of the new 600 hires are! Good job, OGD-keep it up!