新的FDA二类原料药DMF完整性评估指南

20160316 ECA新闻：新的FDA二类原料药DMF完整性评估指南  

16/03/2016

New FDA Guidance on CompletenessAssessements for Type II API Drug Master Files

新的FDA二类原料药DMF完整性评估指南

Since the coming into force of the"Generic Drug User Fee Act" (GDUFA) on 1st October 2012, specialregulations have been applying to the submission to the FDA of a Drug MasterFiles for a pharmaceutical API (Type II DMF). The DMF holder must pay aone-time fee when authorising the reference of his/ her DMF in an applicationfor a generic drug (Abbreviated New Drug Application, ANDA). Moreover, the DMFwill undergo a completeness assessment through the FDA.

自2012年10月1日GDUFA实施以来，已有特定的法规应用于提交给FDA的二类原料药DMF。当授权给一个仿制药（ANDA）申报引用其DMF时，DMF持有人必须支持一次性费用。另外，DMF将要接受FDA的完整性评估。

This year in February, the FDA publisheda Guidance for Industry entitled "Completeness Assessments for Type IIAPI DMFs under GDUFA" which provides DMF holders withcomprehensive information regarding the application for a Type II DMF. Thedocument describes the criteria according to which the FDA performs acompleteness assessment and which data are expected.

本年2月份，FDA公司了题为“GDUFA下的二类原料药DMF完整性评估”的行业指南，其中给DMF持有人提供了关于二类DMF申报的综合信息。文件描述了FDA据以进行完整性审核的依据，以及哪些数据需要包括在里面。

This completeness assessment does notreplace the full scientific assessment to be executed at a later time. Itserves to find out whether the data contained in the DMF are sufficient for theANDA. In a completeness assessment, the following elements are examined:

此完整性审核并不替代全面的科学评估，科学评估要在迟些时候才进行。它是为了发现DMF里面的数据是否足够支持ANDA。在一个完整性评估中，要检查以下要素：

·        Is the DMF active?

·        DMF是激活的吗？

·        Has the fee been paid?

·        费用是否已支付？

·        Has the DMF been previously reviewed?

·        DMF之前被审核过吗？

·        Does the DMF pertain to a single API?

·        DMF只包含有一个API吗？

·        Does the DMF contain certain administrative information?

·        DMF包括有特定的行政信息吗？

·        Does the DMF contain all the information necessary toenable a scientific review?

·        DMF是否含有进行科学审核的必要信息？

·        Is the DMF written in English?

·        DMF是用英语书写的吗？

The Guidance contains a checklist(Appendix 1) listing the criteria according to which the FDA performs theassessment. For the DMF holder, this list is helpful to check the completenessof his/ her data before submitting them to the FDA.

指南中含有一份检查清单（附录1），其中列出了FDA据以实施评估的标准。对于DMF持有人，此清单有助于在将DMF提交给FDA之前检查其数据的完整性。

One essential element underlined in thisGuidance is to pay the DMF fee in due time (at least 6 months prior to thesubmission of an ANDA). The FDA won't continue to process the DMF as long asthe fee hasn't been paid. If the applicant of an ANDA references in his dossiera DMF for which a fee is due, the FDA will inform him. If the fee hasn't beenpaid within 20 days after notification, the FDA will stop the furtherprocessing of the application.

这份指南中暗含的一个基本要素是在指定时间内支付DMF费用（至少在ANDA提交之前6个月内）。FDA不会处理没有支付费用的DMF。如果一个ANDA申报人在其文件中引用一份DMF，而该DMF费用未支付，则FDA会通知ANDA申报人。如果费用在通知之后 20天仍未支付，则FDA会停止对申报的进一步处理。

When submitting a DMF, the form "FDA 3794" (Generic Drug User FeeCover Sheet) should be attached. It contains the minimuminformation required by the FDA to determine whether the DMF holder hassatisfied his fee obligations.

当提交一份DMF时，要附上FDA3794表（仿制药用户费用封面表）。其中包括了FDA确定DMF持有人是否履行其付费义务所需的最少信息。

After the successful completenessassessment of a DMF, a number will be attributed and posted on a publiclyavailable API DMF list. The FDA has compiled all important informationregarding DMFs Type I-V on the Drug Master File webpage.Here, you can also find the list of all active DMFs.

在对一份DMF的完整性评估成功结束后，FDA给DMF赋码，并在公众可以获得的原料药DMF清单上公布。FDA已汇集了DMF一类至五类所有重要的信息在DMF网页上。在那里，你可以找到所有激活状态的DMF的清单。

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