首页 > 资讯 > 2016财年FDA ANDA批准和接收数据已公布

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2016-10-13 Lachman CONSULTANTS

FDA仿制药办公室（OGD）于10月11日发布了2016全财年的批准和接收数据以及一些其它指标。9月份OGD批准的51件ANDA，2016财年总批准量为651件，平均每月54.25件。这至少是过去8年（也许更长时间）在一财年中批准量最高的年份，并且是GDUFA I期批准量最多的一年（之前最高的是2015财年的492件和GDUFA之前的2012财年517件）。这是个好消息！坏消息是2016财年OGD共接收853件ANDA（平均每月71件），超出批准量202件。虽然2016财年还有184件暂时批准，但在OGD的平衡表上仍有一些批准短缺。

令人惊讶的是9月有60件ANDA提交，因为之前我们预测（随着进入2017财年新的审评指标是在10个月内对90%的ANDA采取首次行动）企业可能会等到10月1日之后提交申请，以利用潜在的缩短5个月的审评时钟的优势。除了5个月的时间优势，还有2017财年ANDA费会下跌约6000美元，因此9月份可能会是一个提交量匮乏的月份。虽然9月份提交的60件ANDA低于2016财年平均71件的提交量，但在2017财年最初几个月结束之前我们可能仍看不到较低收费和5个月审评优势的影响。如果相当多的ANDA被滞留没有在2016财年的最后一季度提交以便利用新的审评指标和收费，那么接下来的几个月的数据将会非常有趣。

9月OGD发布193封完全回应函（CRL）成为2016财年的最高月份（之前最高的月份是2016年4月的190封）。2016财年OGD共发布1725封CRL，显著高于GDUFA I期的其它年份（大约高出500封）。

那么2017财年企业将会期待些什么呢？我猜他们的期望会是每月批准数量的持续增长以接近一个数字，可能是接近每个月批准75-80件。他们一定期望实现批准量超越接收量，改善沟通、合规状态和解决方案的更好信息，以及更清晰的指南文件和OGD政策。这些是我的猜测，你们的呢？

Lachman CONSULTANTS - Bob Pollock先生
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Final FY 2016 Approvals and Receipts for ANDAs Just Released
By Bob Pollock | October 11, 2016 原文地址

OGD's final numbers for approvals and receipts and a few other metrics for the full FY 2016 were released today. OGD approved 51 ANDAs in September for a total of 651 for FY 2016, an average of 54.25 ANDA a month. This represents the largest number of approvals in a fiscal year in (at least )the last 8 years (and likely longer) and is the most approved under GDUFA I (previous GDUFA high was 492 which was achieved in FY 2015 and 517 in FY 2012 prior to GDUFA). That’s the good news! The bad news is that OGD received a total of 853 ANDA (71/ANDAs/mo) in FY 2016 which is 202 more ANDA than it approved. It is true there were also 184 tentative approvals in FY 2016 but that still leaves OGD a little short on the balance sheet.

Surprisingly, September saw the submission of 60 ANDAs as we predicted (with the new review metric of 90% of the ANDAs with first action in 10 months to kick in at the start of FT 2017) that firms might wait until after October 1 to submit their application to take advantage of the potential 5-month shorter review clock. In addition to the 5-month advantage, we thought that (with an almost $6000 reduction in ANDA fees for FY 2017) that September would be a lean month for submissions. And while the 60 ANDAs submitted in September is below the monthly average of 71 submitted for FY 2016, we still may not yet have seen the impact of the lower fees and 5-month review advantage until the first few months of FY 2017. That will be an interesting one to watch especially if quite a few ANDAs were held back from submission in the last quarter of FY 2016 to take advantage of the new metrics and fees.

In September 2016, OGD issued the highest number of Complete Response Letters (CRLs) in any month of FY 2016 at 193 (previous high was 190 in April of 2016). For FY 2016, OGD issued a total of 1725 CRLs which is significantly higher (by almost 500 CRLs) than any of the previous GDUFA I years.

So what do we think industry will look for in FY 2017? My guess is that their expectations would be a continued increase in the number of approvals per month to approach a number that maybe closer to 75-80/month. They will certainly expect to attain more approvals than OGD gets ANDA receipts, improved communications, better information on compliance status and resolution, and more clarity on guidance documents and OGD policy. Those are my best guesses. What are yours?