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【讨论】Drug Master File Fee
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这个帖子发布于4年零141天前，其中的信息可能已发生改变或有所发展。
Drug Master File FeeQ1. What DMFs incur fees?Only DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application incur fees. Specifically, each person that owns a Type II API DMF (DMF holder) that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a DMF fee.Q2. What is a generic drug submission?The phrase generic drug submission refers to an ANDA, an amendment to an ANDA, or a PAS to an ANDA.Q3. When is a DMF fee incurred?The owner of a DMF incurs the fee the first time that a generic drug submission references that DMF by an initial letter of authorization on or after October 1, 2012.Q4. What is an &initial letter of authorization& as that term is used in this context?An initial letter of authorization is one that an ANDA applicant has not previously relied on. This means that the DMF fee would be triggered the first time that a DMF is referenced by an ANDA applicant that has not previously relied on a letter of authorization for that DMF. For example, if ANDA applicant X submitted its ANDA (for Drug A) in September, 2012 and relied on a letter of authorization for DMF 11111, it would not trigger a fee for the DMF. If after October 1, 2012, ANDA applicant X amended or supplemented its application, it would not trigger a fee for the DMF. If, however, after October 1, 2012, ANDA applicant X submitted a new ANDA (for Drug B) with a letter of authorization to DMF 11111, it would trigger a fee for DMF 11111.Furthermore, if a different ANDA applicant submitted a letter of authorization to DMF 11111 after October 1, 2012, it would trigger a fee for the DMF, if the fee had not already been paid for DMF 11111. Once a fee is paid for DMF 11111, no additional fee for this DMF will be assessed, regardless of how many letters of authorization for that DMF are referenced in one or more ANDAs.Q5. Do holders of DMFs submitted and reviewed by FDA before October 1, 2012, have to pay a DMF fee?GDUFA does not make a distinction between DMFs submitted before or after October 1, 2012. Holders of DMFs reviewed prior to GDUFA implementation must pay the one-time DMF fee if their DMF is referenced in a new generic drug submission on or after October 1, 2012.Q6. Will DMF holders be charged each time their DMF is referenced?No. The DMF fee is a one-time fee, incurred on first reference of the DMF on or after October 1, 2012. This fee is not incurred every time a DMF is referenced.Q7. How much is the DMF fee? The DMF fee for fiscal year (FY) 2013 (October 1, 2012 to September 30, 2013) is $21,340.
Additional information, including the methodology for calculating the fee, is available in .Fees for FYs
will be adjusted for inflation and other factors, including the projected number of DMFs that FDA expects to be referenced for the first time in a given year based on experience. Fees will be published in the Federal Register no later than 60 days before the start of each fiscal year.Q8. When will the DMF fee be due?In FY 2013, DMF fees will be incurred at the time of submission of a generic drug submission for all Type II API DMFs referenced for the first time by an initial letter of authorization on or after October 1, 2012. In general, fees will be due on the date the first generic drug submission is submitted that references the associated DMF.On October 25, 2012, a notice was published in the Federal Register regarding FY 2013 generic drug user fee rates for Type II DMFs, ANDAs, and PASs.
The notice was required by the GDUFA statute (PL 112-144), see FDCA §744B (a)(2)(C)(i), (a)(3)(B)(i).
That statute sets the due date for fees for certain Type II DMFs and generic drug submissions 30 calendar days after publication of the notice, see §744B(a)(2)(E)(ii)(I), (a)(3)(C)(ii)(II).
Thirty calendar days after October 25, 2012 is November 24, 2012, which is a Saturday.
Given that this is not a business day for the U.S. Government, the fee due date will be the next business day.
Fees received on or before Monday, November 26, 2012 will be deemed to have been submitted on or before the due date.
Thus:FY 2013 Type II DMF fees are due on or before the later ofthe date on which the first generic drug submission is submitted that references the DMF via an initial letter of authorization on or after October 1, 2012, orNovember 26, 2012.Fees for FYs
will be due no later than the date on which the first generic drug submission that references the associated DMF holder’s file is submitted.Q9. Do DMF holders need to wait for a new ANDA applicant to request a letter of authorization before the DMF is assessed to be available for reference?No. DMF holders can pay the fee before a letter of authorization is requested. The DMF will then undergo an initial completeness assessment, using factors that FDA will articulate in forthcoming guidance. If the DMF passes the completeness assessment, it will be placed on a publicly available list of DMFs available for reference.Q10. What are the criteria for a DMF completeness assessment?Please see .Q11. Can an ANDA applicant pay the DMF fee for an API referenced in its submission?Yes.Q12. What is the penalty for failure to pay the DMF fee?The DMF will be deemed not available for reference. Once the DMF fee becomes due, no generic drug submission submitted on or after October 1, 2012, referencing the DMF will be received unless the fee is paid and the DMF is deemed available for reference.Note: The DMF fee does not become due until FDA announces the amount of the fee. Please note that this is a change resulting from the recent enactment of the FDA User Fee Corrections Act of 2012 which enables collection of FY 2012 GDUFA user fees without enactment of an appropriations act.ANDA applicants that reference a DMF for which a fee is due but has not been paid will be provided notification of the DMF holder’s failure to pay. If the DMF fee is not paid within 20 calendar days after notification, the ANDA referencing the DMF will not be received.-Related Information
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对于Type II的DMF，需要在完成completeness assessment之后才能被引用，通过CA后名单可在下述网址下载到The list of DMFs that have passed the Completeness Assessment and are available for reference by ANDAs under GDUFA is available at 而在总的DMF list（包括各种类型DMF）中，仅有A, I, P, N四种状态，无C
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cindy66 请问 大侠Related Information这个在哪里能找到，如何查询？茫茫的pda官网中，怎样可迅速找到？ 在STATUS OF DMFS下面
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DMF fee交了之后听说要另册管理，这个说法有官方的文件吗？
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US TYPE II DMF技术审查后status是A还是C？？
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bonny2000 US TYPE II DMF技术审查后status是A还是C？？STATUS OF DMFS“A” = Active. This means that the DMF was found acceptable for filing, administratively, and has not been closed.“C” = Complete.
This means that the DMF has undergone a successful
(current as of 3/28/2013)“I” = Inactive.
This means a DMF that has been closed, either by the holder or by the FDA.“P” = DMF Pending Administrative Filing review“N” = Not an assigned number.
This can occur for a number of reasons, e.g., the holder withdrew the DMF during the administrative review or the DMF was transferred to another Center.Note that the Administrative Filing review is not related to the “Initial Completeness Assessment,” which is performed for Type II DMFs submitted to support ANDAs ONLY.
The status conveys no information about whether DMF has been reviewed for technical content.
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STATUS OF DMFS“A” = Active. This means that the DMF was found acceptable for filing, administratively, and has not been closed.“I” = Inactive.
This means a DMF that has been closed, either by the holder or by the FDA.“P” = DMF Pending Administrative Filing review.“N” = Not an assigned number.
This can occur for a number of reasons, e.g., the holder withdrew the DMF during the administrative review or the DMF was transferred to another Center.Note that the status “C,” which meant that a DMF had passed the Completeness Assessment, has been removed and replaced with “A”, since the list of those DMFs is updated more frequently than this list of all DMFs. This won't puzzle us and only A
in future .
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llb1978 STATUS OF DMFS“A” = Active. This means that the DMF was found acceptable for filing, administratively, and has not been closed.“C” = Complete.
This means that the DMF has undergone a successful
(current as of 3/28/2013)“I” = Inactive.
This means a DMF that has been closed, either by the holder or by the FDA.“P” = DMF Pending Administrative Filing review“N” = Not an assigned number.
This can occur for a number of reasons, e.g., the holder withdrew the DMF during the administrative review or the DMF was transferred to another Center.Note that the Administrative Filing review is not related to the “Initial Completeness Assessment,” which is performed for Type II DMFs submitted to support ANDAs ONLY.
The status conveys no information about whether DMF has been reviewed for technical content.是不是只有显示“A”状态的产品才有可能被制剂厂家使用。显示“I”
状态是不是表示目前RLD制剂不可能使用到这个厂家的API?
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对于Type II的DMF，需要在完成completeness assessment之后才能被引用，通过CA后名单可在下述网址下载到The list of DMFs that have passed the Completeness Assessment and are available for reference by ANDAs under GDUFA is available at 而在总的DMF list（包括各种类型DMF）中，仅有A, I, P, N四种状态，无C
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太赞了！收藏
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请问 大侠Related Information这个在哪里能找到，如何查询？茫茫的pda官网中，怎样可迅速找到？
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cindy66 请问 大侠Related Information这个在哪里能找到，如何查询？茫茫的pda官网中，怎样可迅速找到？ 在STATUS OF DMFS下面
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是否可以这么理解，只要是进入CA名单的，DMF状态一定是“A”，也就是说进入CA名单的API均可以被引用？
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