FDA最新仿制药审评数据
出自识林
FDA最新仿制药审评数据
笔记 2015-02-28 Lachman CONSULTANTS 仿制药办公室（OGD）2015财年仿制药计划行动报告 刚刚发布其1月效率数字，拒绝接收（RTR）数量达到30，与GDUFA实施以来的最高月份（2013年10月）持平。OGD在GPhA年会时提到RTR行动方面的预期增加。这可能意味着对最初第3年队列申请的更严格审查，因为OGD现在需要面对与这些申请相关的指标。 本月批准量达到25件，是到目前为止2015财年的最低批准量。如果根据本财年前4个月的数字作线性估计，2015财年OGD预计批准381件ANDA（相比于2013财年的440件和2014财年的409件）。再来看看接收情况，1月OGD共收到27件ANDA。同样根据前4个月的数字作线性估计，OGD预计本财年将接收438件ANDA（相比于2013财年968件和2014财年1254件）。 因此，至少到现在为止，接收量显著下降，批准量看起来比接收量低10%。然而，接收量仍超过批准量，这意味着OGD仍将继续与不断增长（尽管以较慢速度增长）的积压作斗争。 1月份完全回应函（CRL）的数量增加到104封，使得前4个月的平均值提高到每月79.5封。好消息是，2015财年至今CRL的发布量每月都有所增加。OGD似乎在增补方面取得了巨大成功。这些类型的增补显然会影响GDUFA审评时限。 但是，如果不知道每件ANDA有多少增补提交，那么除了这条信息代表了大量的工作和OGD的跟进，从中无法作出更多推断。 2015财年，变更待批（CBE）补充申请以每月428件的速度提交，而之前已获批申请的补充申请（PAS）以每月37件的速度涌进。这些数字在前两个财年并没有明确跟踪，本财年报告有关于这些补充申请的大量修订。 本财年已经过去三分之一，企业界仍在寻找审评效率的进展。一些迹象是积极的，但估计企业界仍在等待突破性的数字。 编译：识林-椒 2015-02-28 OGD's January Productivity Stats are In – What Do We See? The Office of Generic Drugs (OGD) just released its January productivity numbers and there are some interesting observations to share. First, the number of Refuse-To-Receive (RTR) actions hit 30, which ties the highest number of (October 2013) since the implementation of GDUFA. This is most interesting because OGD made mention of an anticipated increase in RTR actions at the GPhA Annual Meeting. This could also mean greater scrutiny for initial year three cohort applications, since OGD now has metrics associated with those applications. Approvals for the month hit 25 which, so far, is the lowest number of approvals in FY 2015. If we straight-line that number for the first 4 months of the FY, one would expect OGD to approve about 381 ANDAs in FY 2015 (compared with 440 and 409 in FY 2013 and 2014, respectively). Looking at the receipts end of things, OGD received 27 ANDAs in January. Again, straight-lining the first 4 months numbers, OGD can be expected to receive about 438 ANDAs this FY (compared with 968 and 1254 in FY 2013 and 2014). So, receipts are significantly down – at least so far- and approvals likely about 10% lower . However, the number of receipts still outpaces the number of approvals, which means OGD will still be playing catch up with the backlog which is likely still expanding (albeit at a slower rate). Complete Response Letters (CRL) increased to 104 in January to yield a 4 month average of 79.5 CRL per month. The good news is that CRLs issued have increased each month so far in FY 2015. The big hit that OGD is taking appears to be in the amendments arena. These types of amendments obviously may impact the GDUFA review clock. But, without knowing how many amendments are being submitted to each ANDA, not much can be inferred from this information, other than it represents a lot of work and tracking for OGD. Changes Being Effected (CBE) supplements are being submitted at the rate of about 428 per month in FY 2015, while Prior Approval Supplements(PAS) are coming in at a rate of 37 per month in FY 2015. These numbers were not explicitly tracked in prior FY under GDUFA. And there are plenty of amendments coming into these supplements (see entire FY 2015 report here) So now we are one-third through this current fiscal year and industry is still looking for progress on the productivity side. Some indications are positive but my guess is that industry is still waiting for a big breakthrough in the numbers. |