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出自识林

2016-01-04 Lachman CONSULTANTS

【更新】：仿制药办公室（OGD）更新了其2016财年仿制药行动报告，12月ANDA接收量为180件，比我们之前报道的175件略多。线性估计2016财年ANDA接收量为1032件，但不太可能以每月180件的速率持续增长。至少我敢肯定OGD不希望如此。

2015年的最后一个月，可能代表着仿制药批准的新常态，但也显示出一些关于申请递交令人担心的迹象。仿制药办公室（OGD）在12月创下新的记录，79件完全批准和20件暂时批准，本月对于原始ANDA共计99件批准行动。

OGD审评机器以相当大的程度上受到GDUFA的支持，不仅从资金角度，而且从在招聘和培训方面花费的时间和精力，开始产出希望得到的结果 — 批准。OGD迄今已达到其所有GDUFA目标，并已实施许多非GDUFA要求的改进措施（例如，目标行动日期），以改善审评和批准时间，提高OGD和企业之间的透明度。

尽管2016财年到现在为止我们没有太多数据加以讨论，如果我们对10月到12月的批准量（现在为190件）采取线性规划，OGD在本财年的批准量可能达到760件，远高于GDUFA实施以来（2013-2015）平均每财年440件的ANDA批准量。

这是个好消息！实际上，自2014年6月以来，每个人都在猜测为什么ANDA递交放缓。也许对于企业来说需要花些时间使用符合新要求的用于递交的稳定性数据量补充其产品管线，也许企业刚刚过度压缩生产计划以将3批申报批加塞进制造和生产进度，或者其它什么原因，12月新的原始ANDA递交数量自2014年7月以来首次达到三位数，接收量高达175件。因2014年7月以来的递交放缓使得OGD一帆风顺的审评行动可能会因此遇到一些麻烦。如果我们对整个2016财年的ANDA接收量做线性估计，2016财年可能成为另外一个递交量超过1000件的年份。而GDUFA人员编制的前提是每年接收700-750件ANDA。

无论如何，让我们希望OGD审评机器可以处理抛给它的任何难题。我知道，企业已经准备好（尽管一些企业对一些长长的信息请求和完全回应函感到诧异）期盼GDUFA天际线的那一抹亮色。

Lachman CONSULTANTS - Bob Pollock先生
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ANDA Applicants – WE HAVE A BINGO
By Bob Pollock | January 4, 2016

December, the last month of the calendar year, may (we hope) represent the new normal in the approval of generic drugs. But there may also be signs of concern regarding submissions on the horizon. The Office of Generic Drugs (OGD) had a modern day record in December with 79 full approvals and 20 tentative approvals for a total of 99 approval actions for original ANDAs for the month.

The prediction of Dr. Uhl and yours truly – that the OGD machine built on the back of GDUFA at quite a cost, not only from a dollar standpoint but also from a time and effort in hiring and training – is beginning to spit out the desired result – approvals. OGD to date has meet all of its GDUFA goals and has implemented many non-GDUFA requested remedies (e.g., the Target Action Date) to improve review and approval times, and to increase transparency between OGD and the industry.

While we don’t have too much data to deal with so far for FY 2016, if we project the October-December approvals (now at 190) on a straight line, OGD could hit 760 approvals this fiscal year, well above the 440 average number of ANDAs each FY since GDUFA was implemented (2013-2015).

That’s the good news! For months, actually since June of 2014, everyone has wondered why there was such a slowdown in ANDA submissions. Maybe it has taken industry this long to refill its pipeline with the newly required amount of stability data for submission, or maybe it has just strained the manufacturing schedule to get the 3 exhibit batches squeezed into manufacturing and production schedules, or whatever the reason, December saw the first time OGD hit even close to triple digit new original ANDA submissions with a whopping 175 receipts. This could spell trouble for the clear sailing in review activities that the slowdown has given OGD since July of 2014. If we straight line original ANDAs received for the full 2016 fiscal year, we may be looking at another 1000+ submission year. Remember that GDUFA staffing was premised on receiving 700-750 ANDAs per year.

Anyway, let’s take the good news and hope that the OGD review machine can handle anything thrown at it. I know that industry is ready (albeit somewhat surprised by some of the long information requests and complete response letters) to look for the bright spot in the GDUFA skyline.