递交医药中间体的DMF到FDA需要交费嘛？

zss0928

想请教大家一下 ，递交中间体的DMF文件到FDA需要交费嘛 ？

按DMF分类的话 ，中间体和原料药都属于Type II ,按理应该要收费的吧 ？

场地费的话 ，需要多少 ？FDA会起到对中间体的现场审计嘛 ？审计费用大概多少呢 ？

zss0928

请各位赐教 ，非常感谢 。

beiwei5du

下面仅仅供参考：
其实针对于中间体的DMF一般是不进行收费的！
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319567.htm

Q2. Which 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.
但是需要注意一点的是API的扩展定义：
https://www.morganlewis.com/~/media/files/publication/lawflashclient%20alert/life%20sciences%20and%20healthcare%20lawflash/fda_lf_fdauserfeeact_25july12.ashx
Drug Master File Fees Could Affect Timing of ANDA Filings

As part of GDUFA there are now fees for review of Type II Drug Master Files (DMFs) for active ingredients referenced in ANDAs. The law provides a somewhat expanded definition of “active pharmaceutical ingredient” (API), providing that API also includes “a substance intended for final crystallization, purification or salt formation or any combination of these activities to become the final API.” This expansion may mean that manufacturers of late-stage intermediates will have to pay a facility fee for the intermediate and for the Type II DMF, if applicable.
There are a number of new requirements that accompany the Type II DMF user fees, including the following:
• Each person that owns a Type II DMF that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization will pay an annual fee.
• In order to be referenced in an ANDA, each Type II DMF holder will need to have paid the user fee and not failed an initial completeness assessment of the DMF as defined by FDA.
• Facilities that produce both active ingredients subject to DMFs and finished dosage forms must pay both user fees.
• FDA intends to list publicly all DMFs that have satisfied an initial completeness assessment and paid the relevant fees.
• DMF fees must be paid no later than the date on which the first generic drug submission is submitted that references the DMF.

zss0928

beiwei5du 发表于 2017-11-14 09:21
下面仅仅供参考：
其实针对于中间体的DMF一般是不进行收费的！
https://www.fda.gov/ForIndustry/UserFee ...

递交中间体的DMF之后 ，有原料药API引用我们的中间体DMF也不用交DMF费用嘛 ？

beiwei5du

zss0928 发表于 2017-11-14 09:46
递交中间体的DMF之后 ，有原料药API引用我们的中间体DMF也不用交DMF费用嘛 ？

不用，API方缴费即可

zss0928

beiwei5du 发表于 2017-11-14 09:49
不用，API方缴费即可

非常感谢 。

这样的话我们也不需要注册场地吧 ？也就是说没有场地费产生 ，中间体交了DMF也可以出口美国嘛 ？

问题有点多 ，真的非常感谢 。

beiwei5du

zss0928 发表于 2017-11-14 10:03
非常感谢 。

这样的话我们也不需要注册场地吧 ？也就是说没有场地费产生 ，中间体交了DMF也可以出口美 ...

这方面不是不太懂，你可以咨询一下你们的注册部门可能会比较可靠。

zss0928

beiwei5du 发表于 2017-11-14 17:02
这方面不是不太懂，你可以咨询一下你们的注册部门可能会比较可靠。

我自己就是做注册的 ，头一次接触到中间体的注册。

379103898

zss0928 发表于 2017-11-15 13:32
我自己就是做注册的 ，头一次接触到中间体的注册。

您好，请问您的问题解决了吗？

蒋家伦

您好，请问方便加一下您微信沟通吗，关于中间体的FDA注册有些问题想咨询您一下