[技术帖] 2017年5月5日后, FDA DMF递交必须按照eCTD格式

fruutuun

Currently, there is no requirement to submit or resubmit DMFs in an electronic format. However, beginning on May 5, 2017, new DMFs, as well as all documents submitted to existing DMFs, must be submitted in an electronic format (eCTD), as specified by FDA in the eCTD guidance. See “Guidance for Industry: Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications” (PDF) (May 2015). DMF submissions that are not submitted in eCTD format after this date will be rejected. DMF holders whose DMFs are currently in paper form will not be required to resubmit their entire DMF in eCTD format, after May 5, 2017.

目前，没有要求以电子格式去递交或重新递交DMFs。但是，从2017年5月5日起，新DMFs及递交给现有DMFs的所有文件，都必须按照FDA的eCTD指南说明的电子格式（eCTD）递交。见“工业指南：提供电子格式申请法规——使用eCTD规范的某些人用药物产品申请和相关申请”（PDF）(2015年5月)。在此日期之后，不以eCTD格式递交的DMF申请将会驳回。2017年5月5日后，不会要求现行DMFs是纸质格式的DMF持有人重新递交整个DMF。

Electronic submissions that are 10 GB or smaller in size must be submitted through the Electronic Submission Gateway (ESG). Most DMF submissions fall into this category; therefore submitters are advised to obtain ESG accounts at their earliest convenience. Submissions that are over 10 GB may be submitted on physical media (such as compact disc) to Address for Filing Original DMFs and All Subsequent DMF Documents.(See FDA eCTD Web Page for further information)

电子递交应通过电子递交通道（ESG）递交，不大于10GB。大部分DMF递交属于这个分类；因此建议递交人在方便的时候获得ESG账号。超过10GB时应以物理媒介（如CD）形式递交给归档原始DMFs和所有后续DMF文件的地址。（见FDA eCTD网页以获取进一步信息）。

DMF holders have the option to change the format of an existing paper DMF to eCTD format any time before May 5, 2017. If a DMF holder decides to change the format of a paper DMF to eCTD format, they may continue to use the existing DMF number. If the existing number is four-digits, e.g., 1234, the DMF holder will need to pad left with zeroes to convert the DMF number to a 6-digit format, e.g., 001234 when the DMF is converted to eCTD format. In addition, if the DMF holder chooses to resubmit all of an existing paper DMF in eCTD format, and there are any changes in the content of the DMF as a result of the reformatting (e.g., addition of new or updated information), the Cover Letter for the submission should specify what areas of information have been updated (see Reporting Changes to a DMF).

2017年5月5日前，DMF持有人可在任何时间自主选择改变现有纸质DMF格式为eCTD格式。如果DMF持有人决定改变纸质DMF为eCTD格式，他们可继续使用现有的DMF号。当DMF转化成eCTD格式时，如果现有号码是4位数的，如1234， DMF持有人需要在左边加上0以将DMF号转化为6位数格式，如001234。另外，如果DMF持有人选择以eCTD格式重新递交所有现有的纸质DMF，且因为格式的变换导致DMF内容发生的任何改变（如增加新的或更新的信息），申请的说明信中应就更新的信息进行说明（见报告DMF变更）。

For paper submissions before May 5, 2017 to an existing paper DMF, two copies in paper must be submitted to Address for Filing Original DMFs and All Subsequent DMF Documents.

2017年5月5前的纸质申请及现有的纸质DMF，两个的纸质文件应递交给归档原始DMFs和所有后续DMF文件的地址。

If a CD or DVD copy of the DMF is submitted along with a paper submission the CD or DVD will not be accepted.

如果DMF纸质文件申请的同时附有CD或DVD 副本，该CD或DVD 副本不被接受。

Submissions via e-mail are not accepted.

不接受通过e-mail的递交。

Paper DMFs may be submitted printed on two sides.

纸质DMFs应双面打印后递交。

小美2005

感谢分享，学习了

静水蓝心

谢谢楼主分享

xqliu

比较及时，学习一下啦，谢谢提供分享。

水煮猫爱吃鱼

楼楼，问下纸质版递交DMF不通过代理的话，应该把这个寄到FDA的哪个地址？

赤脚天使

非常感谢楼主分享