首页 > 资讯 > 19天之内ANDA提交量破月度记录和年记录！

出自识林

2014-07-12 识林

本周五（2014年7月11日）的晚些时候，OGD更新了GUDFA“（2014财年）仿制药计划行动报告”。我们都曾预计在6月19日对新提交ANDA的“3批，6个月稳定性”要求实施日期之前会有相当大批量的提交。我个人的看法是在这最后期限之前将有多达750件ANDA。最终结果离这一数字并不是太远。2014年6月新ANDA的提交数量总计635件，其中的绝大多数是在6月1日到19日之间提交的（传言已达598件）。

这显然突破了月度ANDA提交的新记录。我猜测，这其中许多是努力赶在截止日期之前提交了“可疑”或失败的生物研究和/或稳定性研究，但是即使我们对提交总量打个25%的折扣，依然是遥遥领先的最大单月新ANDA总量。我们将不得不等待看OGD如何处理这些ANDA，尤其是他们认为一些已被接收的ANDA有重大缺陷。目前亟待解决的问题是，他们会让试图与系统博弈并赶在“3批截止日期之前”提交的申请人返回去做3批和6个月的加速稳定性研究吗？【不会！参见OGD关于稳定性要求的新决定 识林资讯 2014-07-25】

随着这些新ANDA的提交，还有3个月才结束的2014财年的新ANDA提交量现在是1440件。我预测接下来的3个月ANDA的提交量将非常少，这一财年的最终提交数量可能不会超过1500。 然而，随着这次提交量的猛击，我估计现在有3888件ANDA在OGD待批。积压数量持续增长，在进入GDUFA绩效指标的第一年（2014年10月1日开始），OGD拥有一大堆约4000件ANDA，这实在令OGD非常忧虑。

北京大学药物信息与工程研究中心 - Garth Boehm博士 2014-07-12
校译：识林-椒 2014-07-12

New ANDA Filings – A Record Month and a Record Year all in 19 days!
Written by Garth Boehm • July 12, 2014

Late on Friday July 11, 2014, OGD updated the GDUFA“Activities Report of the Generic Drug Program (FY 2014)” . We were all expecting quite a large number of filings ahead of the June 19th deadline for implementation of the “three batch, six month stability” requirement for new ANDAs. My personal opinion was that up to 750 new ANDAs would be filed attempting to beat this deadline. In the event it was not too far off. The June 2014 new ANDA filing total was 635 with most of those filed between June 1 and June 19 (rumored to have been 598).

This is obviously a new record for a one month filing total for ANDAs. I would guess that many were filed with “suspect” or failing and/or stability studies in an effort to beat the deadline, but even if we discount say 25% of this total, it is still far and away the largest monthly new ANDA total. We will have to wait and see what OGD does with these ANDAs, especially if they deem some to have major deficiencies after they are accepted. The burning question is will they make sponsors go back and make three batches and do six months of accelerated stability for trying to game the system and beat the "3 batch deadline"?

With these new ANDAs filed, the Fiscal Year 2014 new ANDA total is 1440 with 3 months still to go. I will predict that very few ANDAs will be filed in these last three months, we may not even get to 1500 for the FY. However, with this new onslaught of filings I calculate that there are now 3, 888 ANDAs pending at OGD. The backlog continues to grow and it must be a significant concern for OGD that they have a pile of almost 4,000 ANDAs going into the first year with GDUFA performance goals, which will start October 1, 2014.

识林www.shilinx.com，版权所有，如需转载请注明出处