首页 > 资讯 > 7月ANDA提交进入干旱期

出自识林

2014-08-17 Lachman CONSULTANTS

似乎整个行业都试图在2014年6月20日ANDA新稳定性要求生效截止日期之前提交，6月份记录的提交量为635件。现在看来，在OGD看到ANDA提交的正常流量之前会有一定的缓冲期。就像南加州的干旱一样， 2014年7月的提交数据如同上周那5分钟的阵雨没有可测量的降雨量，仅有少量的4件ANDA提交，对比本财年前一个月的ANDA提交量微不足道。这将给OGD一些余地处理过去几个月中已经淹没OGD的大量提交。

下一个大量提交月很可能是2014年10月，这是2015财年的开端，这个月GDUFA指标对于第3队列年的提交生效。另一个我们预测从那个月开始会有更多ANDA提交量的原因是，ANDA提交的GDUFA收费因2011、2012、2013财年的高提交率下降了一些。我不认为2014财年迄今为止近1500件ANDA的提交量在计算2015ANDA GDUFA收费数据时发挥了作用。等到10月31日之后再看看提交数量趋势将会非常有意思。

此外，积极的一方面，OGD收到134件对原始ANDA的增补，这比本财年146件的平均值略低，虽然OGD 7月仅批准了18件ANDA，发出了87封完全回应函，低于2014财年109件的月平均值。我们都相信，随着OGD和OPQ人员完成培训和2014年10月1日队列年指标的开始，OGD预期批准数量和CRL将稳定增长。

Lachman CONSULTANTS - Bob Pollock先生 2014-08-15
校译：识林-椒 2014-08-17

June ANDA Submissions Ran Industry Dry for July!
Written by • August 15, 2014

With what seemed like the entire industry trying to beat the June 20, 2014 submission deadline ahead of the ANDA new stability requirements set to take effect that day, a record of 635 ANDAs were submitted in June. Now it looks like there will be some reload time before OGD sees the normal flow of ANDAs coming in. Just like the drought in Southern California, the July 2014 submission figures looked like the 5 minute rain shower we had last week that produced no measureable rainfall and produced a meager 4 ANDA submissions – almost no measureable ANDAs compared to previous months this Fiscal Year. This will give OGD some room to maneuver around the large number of submissions that have flooded OGD in the previous months.

The next big submission month is likely going to be October 2014, the beginning of FY 2015 and the month the GDUFA metrics take effect for the cohort year 3 submissions. Another reason we may expect more ANDAs beginning that month is that the GDUFA fees for ANDA submissions dropped a bit due to the high submission rate over FY years 2011, 2012, and 2013. I don’t think that the almost 1500 ANDAs submitted thus far in FY 2014 really played into the calculation of the 2015 ANDA GDUFA fee figure. It will be interesting to see how the submission numbers trend after October 31.

Also, on the positive side, OGD received 134 amendments to original ANDAs, which is slightly below this fiscal year’s average of 146, although OGD only approved 18 ANDAs in July and issued 87 complete response letters, which is a bit below their FY 2014 monthly average of 109. We are all sure that OGD anticipates that the approval numbers and (Complete Response Letters) CRLs will increase steadily as OGD and OPQ staff become fully trained and as the October 1, 2014 start of cohort year metrics begins.