四月 - FDA仿制药批准开始好转？
出自识林
四月 - FDA仿制药批准开始好转？
笔记 2015-05-02 Lachman CONSULTANTS 2015年4月是GDUFA实施以来ANDA批准数量最多的一个月，48件ANDA批准和19件暂时批准（TA）。我们希望这反映了GDUFA机器已经开始更快的运行，不再是停滞不前。接下来的几个月，如果批准数量持续上升，GDUFA的前景将更加清晰，因为这意味着过程效率正在提升。GDUFA实施已经有2年半的时间，希望培训工作逐步结束，仿制药办公室（OGD）和药品质量办公室（OPQ）开始看到其经验丰富的审评人员（新手训练师）的努力工作已经开始获得回报。 从外部来评估OGD和OPQ的整个产出并不是一件容易的事情。现在是5月初，而仿制药计划行动报告仅更新到3月。尽管批准数据更明显且易于查找，我们仍在质疑报告那些数字，因为似乎在各种批准报告中继续有滞后登记。例如，4月的实际批准数量是48件（经OGD核实），但FDA月度批准报告显示42件。另外，尽管经OGD确认暂时批准数量是19件，但月度批准报告显示仅有4件暂时批准。我们知道OGD正在设法纠正和协调FDA网站上各种公开报告中关于批准行动的报告（What's New at FDA， FDA月度批准报告，以及仿制药计划行动报告）。有人会认为批准行动实施后第二天将自动显示在报告上，但至今这种情况并非如此，因为在对各种报告格式的更新存在延误，从而对企业人员对照统一这些数据带来困难。我们知道FDA正在努力解决这个问题。 虽然我们尽力提供最准确的可用数据，我们的报道仅根据报道当天的数据做出评价，之后这些数据可能会是会有更新。因此，如果我们报道的数据与OGD的记录不是十分吻合，我们要向OGD致歉，但业界对这些数据的兴趣如此强烈，要求报道及时性的呈现给读者。 Lachman CONSULTANTS - Bob Pollock先生 2015-05-01 Is April the Turn Around Month for Generic Approvals? The month of April 2015 saw the largest number of ANDA approvals since the implementation of GDUFA, with 48 ANDA full approvals and 19 tentative approvals (TAs). That is 65 approval actions and represents a post-GDUFA record that we hope is reflective of the fact that the GDUFA machine has begun to turn faster and may no longer be just spinning its wheels. The GDUFA outlook will be clearer after the next few months if the number of approvals continues to rise, as that will mean the efficiency of the process is kicking in. We are 2.5+ years into GDUFA and, hopefully, the training efforts are winding down and the Office of Generic Drugs (OGD) and Office of Product Quality (OPQ) are beginning to see that the hard work of its experienced reviewers(who are the ones training the newbies) are beginning to pay off. Evaluating the entire output of OGD and OPQ is not an easy task from the outside. Here we are at the beginning of May and the Activities Report of the Generic Drug Program has just been updated for March. While approvals data is more evident and easy to find, we are still questioning what numbers to report, as there appears to continue to be a lag for listing in the various approval reports. For instance, the actual number of approvals for the month is 48 (verified by OGD), but the FDA Approvals by Month Report shows 42. In addition, while the number of Tentative Approvals was confirmed by OGD as 19, the same report shows only 4 TAs. We know that OGD is looking to try to rectify and reconcile the reporting of approval actions in the various public reports on the FDA website (What’s New at FDA, FDA Monthly Approvals Report, and the Activities Report of the Generic Drug Program). One would think that an approval action would trigger next day appearance on the reports, but so far that is not the case, as there are delays in updates to the various report formats making reconciliation of the numbers quite a task for those of us in industry. We do know that the FDA is working on this problem. While we try to provide the most accurate data available, our posts are only as reliable as the data available at the time of the post. Therefore, we apologize to OGD if the numbers we report are not quite consistent with their tally at the time of publication of the post, but with interest in these numbers so intense by the industry, our reports demand timeliness. |