首页 > 资讯 > 2014财年过半—ANDA提交和审评情况概览

出自识林

2014-04-22 Lachman CONSULTANTS

2014财年已过去6个月，一些惊人的提交数字让年迈的OGD脊背发冷。根据2014年4月11日发布的数据，到目前为止，OGD本财年已收到597份新的原始ANDA。这一数字反映了截止到2014年3月底的提交活动。另一方面，OGD在本财年上半年批准了392份ANDA。让我们更仔细地看一下这些数字。

随着几个重要的日期的到来，我们预计将看到ANDA的提交数量扶摇直上。首先，预计ANDA提交数量将于5月份和6月上旬大量增加。为什么？因为2014年6月20日新的稳定性指南将在申请时成为现实，要求3批申报批以及6个月室温和加速稳定性数据。因此，企业将争相在这一时间之前提交ANDA。其次，2014年10月1日，新的2015财年GDUFA付费将生效。所以我们预计会看到9月份ANDA的提交将比较少，因为它们仍然属于2014财年GDUFA付费时间表。

2014财年原始ANDA的平均月提交量是99.5份，如果保持这一速度，OGD本财年预计会收到1194份ANDA，比以往任何一个给定财年收到的申请多大约100份。平均月批准量刚刚超过32份，如果这一速度继续，本财年将批准392份ANDA。这意味着提交和批准之间的差距约为802份，仅比2010财年（GDUFA协商的基准年）提交的ANDA总量少了11份。

显然，基于这些数字对GDUFA工作量和产出的估算，似乎比实际每日提交量所掩盖的现实低了20%。OGD是不幸的，因为GDUFA被设定为5年期限，他们真地无法做任何事情来增加员工。

从积极一面看，OGD在2014财年上半年已经发出694份完全回应函，平均每月116封。但是随着ANDA提交速度为每月100份，并有2800份ANDA或者更多的积压，如果OGD终究希望走出他们自己陷入的困境，总要付出一些代价。

我们当然祝愿OGD好运，希望他们能够找到解决办法，对于原始ANDA和补充申请，都付诸以大量的首轮批准。正如Cook所指出的，“CRL（完全回应函，complete response letters）是无休止的礼物”，意思是OGD无疑将收到一份修订作为对CRL的回应，因此将需要一次又一次的处理申请。或者换一种说法 — 永不完结的故事！

Lachman CONSULTANTS - Bob Pollock先生 2014-04-14
编译：识林-椒 2014-04-22

Half Way Through FY 2014 – A Look at ANDA Submissions and Approvals
Written by Bob Pollock • April 14, 2014

Six months into Fiscal Year 2014 and some staggering submission numbers should send a chill up the old OGD spine. So far, this FY OGD has received 597 new original ANDAs based on numbers released on April 11, 2014. That number reflects activity through the end of March 2014. On the other hand, OGD has approved 392 ANDAs in the first 6 months of this FY. So let’s look at the numbers a bit more closely.

With a couple of important dates coming up, we expect to see the number of ANDA submissions skyrocket. First, expect that the number of ANDA submissions in May and first half of June to be huge. Why? Because on June 20, 2014 the new stability requirements for 3 exhibit batches and 6 months of room temperature and accelerated at the time of filing will become reality. Thus, firms will be rushing in ANDAs trying to beat the clock. Secondly, on October 1, 2014, the new FY 2015 GDUFA fees will go into effect. So we expect to see the September ANDA submissions to be brisk as they will still fall under the FY 2014 GDUFA fee schedule.

The average monthly submission rate for original ANDA in FY 2014 is 99.5 and if that rate continues, OGD can expect to receive 1194 ANDAs this fiscal year, which would be about 100 more than ever received in a given fiscal year. The monthly average approval rate of just over 32, if that pace continues, would yield about 392 ANDAs approved this fiscal year. That would mean the difference between submissions and approvals would be about 802, which is just 11 ANDAs short of the total of ANDAs submitted in FY 2010 (the base year for the GDUFA negotiations).

Clearly, the numbers upon which the GDUFA workload and productivity estimates were based appear to be about 20% lower than the reality of the current day filings belie. Woe is OGD because they really can’t do anything to increase staffing as GDUFA is set for a 5-year period.

On the positive side of the ledger, OGD has issued 694 complete response letters in the first 6 month of FY 2014 for an average of 116 per month. But with ANDA submission rates at about 100 and with 2800 ANDAs or more in the total backlog, something has to give if OGD is ever going to be able to dig out of the hole they find themselves in.

We certainly wish OGD good luck and hope they can figure out a way to make a lot of first cycle approvals for both original ANDAs and supplements. As Cook has said, “the CRL is the gift that keeps on giving” meaning that OGD will undoubtedly receive an amendment in response to the CRL, and thus, will need to deal with the application again and again. Or put another way – the never ending story!