DMF授权信有无有效期？

姜嘉琪

向FDA提交ANDA时，其中需要提供包材（包括包材原料）的DMF授权信。对于该授权信的有效期有具体规定吗？同事说好像在FDA官网上看见过，从授权书开具的时间推算，有一年有效期的规定。但是我并没有找到相关规定，求各位老师解答一下，谢谢！

以斯贴

这个是官网的授权信模板授权信中会明确授权的DMF编号（我理解的DMF NO.是DMF文件编号，而非归档号），如果DMF发生变更，编号会改变，相当于授权信就不再适用了。

姜嘉琪

目前的情况是，DMF没有发生变更，只是生产商开具LOA的日期已经是一年多前了，然后我的一个同事说LOA是有有效期的（1年），过了有效期，需要向生产商重新开具。如果是一年的有效期，那也太短了

姜嘉琪

以斯贴 发表于 2019-3-4 11:45
这个是官网的授权信模板授权信中会明确授权的DMF编号（我理解的DMF NO.是DMF文件编号，而非归档号），如果D ...

目前的情况是，DMF没有发生变更，只是生产商开具LOA的日期已经是一年多前了，然后我的一个同事说LOA是有有效期的（1年），过了有效期，需要生产商重新开具。如果是一年的有效期，那也太短了

以斯贴

LETTERS OF AUTHORIZATION (Category 2)

All Letters of Authorization (LOAs) should be submitted in two copies to the DMF, if the DMF is in paper format.  If the DMF is in CTD format, whether in paper or eCTD, the LOA should be submitted in Section 1.4.1.  A copy of the LOA must then be sent by the DMF holder to the Authorized Party (company or individual authorized to incorporate the DMF by reference).  Failure to submit the original LOA to the DMF may result in a delay in review of the DMF. LOAs should specify the name of the specific item being referenced and the date of the submission of information about that item. The LOA should not be called a “Letter of Access.”
An LOA should be submitted even if the DMF holder is the same company as the authorized party.
LOAs should NOT be submitted with original paper DMFs (unless the DMF has received a pre-assigned number) because the LOA should contain the DMF number. Therefore, if there is no pre-assigned number, DMF holders should wait before submitting an LOA until they have received an acknowledgment letter containing the DMF number.
It is not necessary to reissue LOAs if there have been no changes in the holder, authorized party, subject of the DMF or item referenced.
If the holder changes its name, whether this represents a change in ownership or not, new LOAs should be submitted to the DMF and copies sent to the authorized party(ies).
If an authorized party changes its name, the new authorized party should request a new LOA from the DMF holder.  Failure to do so may result in a delay in review of the DMF.
If there has been a name change, it is not necessary to submit a Withdrawal of Authorization Letter for the holder or authorized party’s previous name.
If a company has a Master File submitted to another Center in the FDA, e.g. a Biologics Master File (MF) submitted to the Center for Biologics Evaluation and Research, the Letter of Authorization should be submitted to the Master File in that other Center rather than CDER.

姜嘉琪

以斯贴 发表于 2019-3-4 12:37
LETTERS OF AUTHORIZATION (Category 2)

All Letters of Authorization (LOAs) should be submitted in  ...

好的，谢谢老师！！！！

demexiao

谢谢分享~~~~

皮皮风云

FYI，中文版
•即使DMF持有者与被授权方为同一家公司，授权信（Letters of Authorization，LOA）同样必须签署；
•如果DMF持有者、被授权方、DMF名称或引用部分没有改变，则LOA不需要重新签署；
•如果DMF持有者改变名称，无论这是否为持有权的改变，LOA都必须重新签署并提供给被授权方；
•如果被授权方改变名称，应当向DMF持有者要求重新签署LOA。 如未能及时签署，可能会延误DMF审评；
•如果持有者或被授权方的名称改变，无需对于原有LOA进行撤销；
•DMF在持有者在提交LOA给FDA时，应递交到对应的审评中心，如CDER，CBER等。
•
一份LOA中不应有多个被授权方；DMF持有人应为各方提交单独的LOA