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出自识林

2016-08-06 Lachman CONSULTANTS

根据2016财年除批准、暂时批准和原始ANDA接收之外的指标9个月的更新数据显示，仿制药办公室（OGD）大多数指标数据呈现更高趋势。

Activities Report of the Generic Drug Program (FY 2016)

一些指标仅在过去两年中有报道（GDUFA目标的第一年和第二年）。这是因为这份仿制药报告的格式在2015财年有更改，因此，难以确定与GDUFA最初两年相应指标数据的关系。例如，变更待批（CBE）补充申请单独于2015财年开始报道。2015财年有5361件CBE递交，2016财年截止6月底，已接收4112件CBE补充申请（以目前速率预计全年将有5483件CBE递交，仅比去年略高）。之前已获批申请的补充申请（PAS）的情况也类似，2015财年共480件，2016财年截止6月底共341件，预计全财年将有455件（同比略有下降）。

过去四年期间一直有报道的指标类别为药物主文件（DMF）完整性审查、完全回应函（CRL）和原始申请的拒绝接收（RTR）行动。GDUFA四年期间这些指标的数据以及2016财年截止6月底的实际数据和2016财年的全年预估数据见下表。

这些数据的走势非常清楚合理。例如，人们会预期DMF完整性审查的数量会减少，因为这种审查仅需要做一次，由于多家企业可能引用同一DMF，DMF的递交数量相对较低。而人们预期CRL会有所上升，而且由于OGD和药品质量（OPQ）办公室组织人员的增补和充分培训，产出会变得更加高效，因此这一数字会继续增加。由于随着时间的推移对ANDA的递交要求也越来越严格，RTR函的数量在GDUFA期间逐年递增。随着OGD进一步描述其RTR标准，以及工业界对RTR标准更加熟悉，但愿我们将在未来几年看到RTR函数量的下降。

Lachman CONSULTANTS - Bob Pollock先生
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Update of 2016 Activities Report of Generic Drug Program
By Bob Pollock | August 3, 2016 原文地址

Based on the updated numbers for 9 months of 2016 for metrics other than Approvals, Tentative Approvals, receipts of original ANDAs, which were reported on in a previous blog post (here), Office of Generic Drug (OGD) numbers point mostly towards higher numbers.

Some metrics have only been reported in the same context for the last two years (first years of GDUFA goals). That is because the format of the reporting from this Generic Report was changed in FY 2015 and it is, therefore, difficult to determine the relationship of some of the reporting number for the first two years of the program. For instance, for Changes Being Effected (CBE) supplements were separately reported only beginning in FY 2015. That year saw submission of 5361 CBEs and, so far, through June 2016, OGD had received 4112 CBE supplements (projection for the full year at current rate would be 5483 or just slightly higher than last year). The situation is the same for Prior Approval Supplements (PAS), which came in at 480 in FY 2015 and, thus far in FY 2016, stands at 341 through June with a projection of 455 for the full FY (or a slight decrease).

Categories of metrics that have been consistently reported over the 4-year period of GDUFA are Drug Master File (DMF) completeness reviews, Complete Response Letters (CRLs) and Refuse-to-Receive (RTR) actions on original applications. The numbers for those metrics for the four GDUFA years along with actual numbers through June and projections for the full FY 2016 are provided in the chart below.

The trend in the numbers make perfect sense. For instance, one would expect the number of completeness acceptability reviews for DMFs to decrease, since this review is only done a single time and the number of DMFs submitted are relatively low, since multiple firms may reference the same DMF. CRLs look to have risen, and that is to be expected since the organization of OGD and Office of Product Quality (OPQ) are staffed up and fully trained, and that number should increase, as these groups becomes more efficient with output growing. The number of RTR letters have risen each FY of the GDUFA program, as the requirements over time have become more stringent. As OGD further outlies its RTR criteria and as industry becomes more familiar with it, hopefully, we will see a decline in that number over the years to come.

We anxiously await the approval and receipt figure for July, which should be published in a few days, and we will report on those as soon as they are posted.