首页 > 资讯 > 6月20日之前本月ANDA递交数量已达600件

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2014-06-23 Lachman CONSULTANTS

仿制药办公室（OGD）20日证实，在新的稳定性要求于2014年6月20日生效之前匆忙递交的ANDA申请数量已经超过所有预期估计，多达600件（非官方数据为598件）。OGD对这一递交数量感到震惊，之前预测的数量在350件左右。我也输掉了与Kurt Karst的晚餐赌注，当时他预测有300件，而我押大约250件以下。天哪，我输掉了赌注！

6月20日最后期限前的4个工作日的高峰中共提交了370件ANDA。至少我们从OGD得到的一个积极的评论是，电子网关可以处理如此巨大的提交量！但是，这对于OGD和FDA来说似乎是仅有的好消息，因为这意味着截止到今天，距6月份还有10天，距本财年结束还有3个多月，2014财年OGD已经接收了1400件ANDA。OGD预计在未来3个月里提交数量会少一些，但本财年末提交数量仍能很容易的达到1500件。因为这是一个友好的博客，对于这个数字我无法发表自己的真实反应。

ANDA的大雪崩意味着OGD和CDER与整个GDUFA计划相关的麻烦，即使在第一年和第二年队列的申请没有与指标相关联，他们仍不得不审评这些申请。也许需要新的第一和第二年队列积压费用于处理到目前为止GDUFA前两年惊人的提交数字（超过2500）。

在接下来的几个月中跟踪拒绝接收（RTR）的统计数据将会是件有趣的事情，我敢肯定这600件ANDA中很多是匆忙间提交给FDA的。这也引发了另外一个先前考虑过的有趣问题—如果ANDA在2014年6月20日之前提交，但是收到RTR函，再次提交时该ANDA需要符合新的3批/6个月稳定性数据要求吗？这个问题今早摆在OGD的面前，我们将会在得知OGD最终的解释/决定后向大家报告结果。

随着队列中新增600件ANDA等待完整性和可接收性审评，企业可能要在6-8个月或者更长的时间之后才能得知自己的ANDA是否被接收！稳定性问答指南解决了6月20日之后ANDA提交增补的问题（例如，一件ANDA提交一个新的规格），但是未定义提交是否仅意味着ANDA原始提交的日期，还是收到RTR函的ANDA也算作提交。我们希望后者同时适用于OGD和企业，因为围绕对指南中D.Q1回答的解释（转述如下）如果必须具有额外的2批和6个月稳定性数据，可能意味着在修订一件收到RTR函的ANDA时的重大延迟。

在FDA稳定性指南终稿生效日期之后，待批ANDA提交的所有增补都将适当考虑原始ANDA提交时的稳定性数据标准，除非是出于对提交的稳定性数据的担忧。

在问题或答案中都没有提到RTR，肯定需要对此作出澄清。企业只有得到关于ANDA可接收性的正式通知后才不会烦恼。

所以，当我们继续前进，攀登变得愈来愈艰难，朝着ANDA批准的上山跋涉变得更加陡峭且遥远。我们还能指望10月初（2015财年伊始）的提交吗？据我们了解许多企业打算推迟到10月1日提交，届时首个ANDA审评的GDUFA指标开始生效。那会是另一个超乎想象的高提交月吗？再有就是通常的日历年底12月的匆忙提交，将会是什么样子？似乎有越来越多的可见的年度匆忙提交月！GDUFA过去两年内的特别大量的ANDA提交将如何影响ANDA和增补提交费用？当计算ANDA付费时，FDA会将这不寻常的600件ANDA量考虑进去吗？GDUFA确实在它两年的存在中产生了许多多于答案的问题。

Lachman CONSULTANTS - Bob Pollock先生 2014-06-20
校译：识林-椒 2014-06-23

Holy Moly! Buckle Up! The Blip Turns Out to Be Mount Everest with about 600 ANDAs in June so Far!
Written by Bob Pollock • June 20, 2014

The Office of Generic Drugs (OGD) confirmed today that the rush to get ANDA applications into the Agency before the new stability requirements go into effect on June 20, 2014 flew past all estimates and landed at just under 600 (the unofficial count is 598). OGD was shocked by the number of submissions with many there predicting a figure around 350. I lost a dinner bet with Kurt Karst who predicted 300 and I picked the under of around 250. Boy, did I lose!

The rush was certainly on with a total of about 370 ANDAs submitted in the last 4 business days leading up to the June 20 deadline. One positive comment from OGD was at least we know the Electronic Gateway can handle the volume! But, that appears to be the only good news for OGD and the Agency as that means that, as of today and with 10 days left in June and with 3 more months until the fiscal year ends, OGD has already received 1400 ANDAs in FY 2014. OGD expects numbers to be light over the next three months but they still could easily reach 1500 by the end of the Fiscal Year. Because this is a family-friendly blog, I cannot print my true reaction to that number.

This avalanche of ANDAs means trouble for OGD and CDER relative to the entire GDUFA program- even though applications in cohort years 1 and 2 do not have metrics associated with them, they still have to be reviewed. Maybe there needs to be a new cohort year 1 and 2 backlog fee to address this staggering number of submissions (over 2500) so far under the first two years of GDUFA.

It will be interesting to follow the Refuse-to-Receive (RTR) statistics over the next few months as I am certain that many of this group of 600 ANDA were likely rushed into the Agency. This also raised another interesting question that has been previously pondered – if an ANDA is submitted before the June 20, 2014 date but receives a RTR letter, will the ANDA need to meet the new 3 batch/6 month stability data requirements on resubmission? That question was posed to OGD this morning and we will report on the outcome when we hear the final OGD interpretation/decision.

With 600 more ANDAs in the queue for completeness and acceptability review, it may be 6-8 months or more before a firm learns if its ANDA has even been received! The Q&A Stability Guidance addresses amendments to ANDAs submitted after June 20 (for instance, a new strength submitted in an ANDA) but does not define if submission means just that, the date the ANDA was originally submitted, or whether an ANDA that receives an RTR letter is considered submitted. Let’s hope the latter applies for both OGD and industry’s sake, because the battles over this interpretation of the answer to D.Q1 in the Guidance (reproduced below) could mean substantial delays in amending an RTR-ed ANDA if two additional batches and 6 months stability data must be generated.

All amendments submitted to pending ANDAs after the effective date of the final FDA stability guidance will be held to the standards in place concerning stability data at the time of the original ANDA submission, unless there is a concern with the submitted stability data.

With no mention of RTR in the question or answer, this is certainly something that needs to be clarified so industry does not fret until they get the word on ANDA acceptability.

So as we move forward, the climb gets tougher, the uphill trek towards ANDA approval gets steeper and clearly longer. What can we expect for submissions beginning in October, the start of FY 2015, as we understand many firms are delaying submissions until October 1 when the first GDUFA metrics for ANDA review kick in? Will that be another unexpectedly high submission month? Then there is the usual end of calendar year December rush – what will that look like? Seems like there are more and more submission rush months being seen every year! How will the extraordinarily large number of ANDAs submitted over these 2 years of GDUFA impact ANDA and supplemental submission fees? Will the Agency take into account this unusual bolus of 600 ANDAs when calculating the ANDA fee? GDUFA has certainly generated many more questions than answers so far in its two year existence.

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