与ANDA审评和优先级相关的两份MaPP
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与ANDA审评和优先级相关的两份MaPP
笔记 2014-08-04 识林, Lachman CONSULTANTS FDA今日发布了两份新的MaPP：5200.4原始ANDA、增补和补充的审评管理标准和程序，5240.3 原始ANDA、增补和补充审评的优先级（2006年旧版题为“原始ANDA、增补和补充的审评顺序”MaPP的修订版本）。这两份MaPP描述了仿制药办公室将如何优先审评ANDA。在过去的文章中，我们曾讨论过对GDUFA第1年和第2年队列没有相关指标的ANDA将如何处理的担心。我们现在似乎可以从这份MaPP了解到 — 除了根据这两份文件列出的优先事项接收快速审评的申请或补充，第1年和第2年队列申请将依据作为审评资源许可的先到先审原则进行审理。虽然这可能会让企业非常不开心，但那些有资格快速审评的申请或补充的企业，或有GDUFA目标日期的企业可以稍微安心些了。 MaPP 5200.4 “描述了仿制药办公室（OGD）的标准和程序，项目管理处领导将管理仿制药提交的审评。” “MAPP 5240.3 Rev.1确认了公共卫生优先的提交类别，包括，根据21 CFR 314.94(a)(12)（某些事“潜在的首个仿制产品”）含有专利证书的提交；与药品短缺有关的提交；属于特别审评项目如艾滋病救济总统紧急计划的提交。 企业、消费者和其他利益攸关者对于可预测的及时的公共卫生优先提交具有强烈的兴趣。加快此类提交的审评是2012仿制药使用者付费修正案（GDUFA）的一个重要目标” 现在MaPP 5240.3的实施将决定OGD的所有申请、增补和补充的审评优先事项。优先级类别包括： 1）根据21 CFR 314.94(a)(12)（某些事“潜在的首个仿制产品”）含有专利证书的提交 MaPP定义了一组与受到特定专利和排他性保护的加速和优先申请或补充相关的相当复杂的条件。大多与该具体主题相同，但也有一些变化。例如，审评时间符合30（或40个月）暂时批准或最终批准，要求比如不引起180天专营权的丧失在MaPP中有具体讨论。同时，“取决于专利到期（即，含第III段认定的提交）的，或取决于专营权到期的提交的批准，OGD和OPS/OPQ将试图以在最后适用专利到期日期或专营权到期日期之前许可批准的方式完成审评。然而，对于在2014年10月1日或之后提交的ANDA：
仔细阅读这些文件，准备好确认任何你认为符合优先审评的申请，并确保让OGD知道该申请。我们将拭目以待这两份文件是如何被业界接收的。我们的猜测是将会几家欢喜几家愁！ Lachman CONSULTANTS - Bob Pollock先生 2014-08-04 Garth Boehm 博士点评我从来没有见过专利到期之前12-30个月的“窗口期”作为“捆绑式”审评的时间区间的。这是很重要的信息，尽管我认为是不明智的。 英文原文2 New MaPPs (to Somewhere) that Provide Direction on ANDA Supplements and Amendments The 2 new MaPPs: 5200.4 Criteria and Procedures for Managing the Review of Original ANDAs, Amendments and Supplements (here) and 5240.3 (a revision of the old 2006 MaPP entitled Review Order of Original ANDAs, Amendments and Supplements) Prioritization of the Review of Original ANDAs, Amendments and Supplements (here) were released today by FDA. These two MaPPs describe how the Office of Generic Drugs (OGD) will prioritize review of ANDAs. In previous blog posts, we have discussed a concern about what will happen to cohort year 1 and 2 GDUFA ANDAs since there are no metrics associated with them. It appears from this MaPP that we now know – except for applications or supplements that receive expedited review based on the priorities outlined in these two documents, the cohort year 1 and 2 applications will be reviewed on a first-in first-reviewed basis as review resources permit. While this may not make industry very happy, those firms having applications or supplements that qualify for expedited review or have a GDUFA goal date may rest a little easier. MaPP 5200.4 “describes the criteria and procedures by which the Office of Generic Drugs (OGD), Division of Project Management leadership will manage the review of generic drug submissions.” “MAPP 5240.3 Rev.1 identifies categories of submissions that are public health priorities, including submissions containing patent certifications pursuant to 21 CFR 314.94(a)(12) (some of which are “potential first generic products”); submissions related to drug shortages; and submissions that are subject to special review programs such as the President’s Emergency Plan for AIDS Relief. Industry, consumers and other stakeholders have a strong interest in the predictable and timely review of public health priority submissions. Expediting the review of such submissions is a key aim of the Generic Drug User Fee Amendments of 2012 (GDUFA).” The implementation of MaPP 5240.3 now will dictate the review priorities of all applications, amendments and supplements at OGD. The categories for prioritizations include: 1) Submissions containing patent certifications pursuant to 21 CFR 314.94(a)(12) The MaPP defines a rather complex set of conditions relative to expediting and prioritizing applications or supplements that are subject to certain patent and exclusivity protection. Much is the same on this specific topic but there are a few changes. For instance, timing of review to meet the 30 (or 40 months) tentative approval or final approval requirements such as not to cause forfeiture of 180-day exclusivity is specifically discussed in the MaPP. Also “[W]here a submission’s approval is dependent on the expiration of a patent (i.e. the submission contains a Paragraph III certification), or is dependent on the expiration of an exclusivity period, OGD and OPS/OPQ will seek to complete review of the submission in a manner that would permit approval prior to the last applicable patent expiration date or exclusivity date. However, with regard to ANDAs submitted on or after October 1, 2014: ANDAs submitted within one year of the last applicable patent expiration date or exclusivity date will not be considered for expedited review, and no assurances can be provided that review will be completed in a manner that would permit approval by the last applicable patent expiration date or exclusivity date. This provision may be subject to exception in certain cases where it is determined that the submission must be expedited to address a public health concern. These determinations will be made by the OGD Division of Project Management and OGD management in consultation with other Agency personnel as necessary. ANDAs submitted more than 30 months in advance of the last applicable patent expiration date or exclusivity date will not be considered for expedited review.” Read these documents over carefully and be prepared to identify any application your believe qualifies for priority review and make certain OGD knows about the application. We will keep our ears open to see how these two documents are received by the industry. Our guess is that there will be some smiles and some tears! 识林www.shilinx.com，版权所有，如需转载请注明出处 |