NEWS & EVENTS

Recently the FDA announced an extension on its new requirement for e-filing of all DMFs, include Type III for Packaging.
https://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/electronicsubmissions/ucm153574.htm

Important Dates

After the dates listed below, eCTD requirements for submissions to CDER and CBER will go into effect and submissions that do not use eCTD will not be filed or received.

May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.

May 5, 2018: Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.

This update impacts two groups in pharmaceutical packaging, and if you belong to one of these two groups, you need to execute a plan as soon as possible.

1. Holders of Type III DMFs.
2. Holders of Submissions that cite (include references) to Type III DMFs.

If you belong to either of these two groups, please note the following important information.

Holders of Type III DMFs

Effective May 5, 2018, the FDA requires that all DMF submissions be in eCTD format. If they are not received in this format, your submission will be rejected. This includes all any submissions to your existing DMF, such as LOAs, Annual Reports and Amendments. Of course, any new DMF will be required to be submitted on the eCTD format.

What is not required

You are not required to re-do the original DMF in eCTD format at this time. Please consult with Montesino or another expert, however, if you plan to reorganize or make significant additions to your DMF, as under these circumstances it may be in your best interest to convert your existing DMF into eCTD format.

What is required

1. eCTD submissions sized 10 GB or less must be submitted via the Electronic Submissions Gateway (ESG) – this includes the vast majority of Type III DMFs
2. Electronic Submissions must use the eCTD version currently supported by the FDA (this is subject to change). https://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/ucm2005545.htm
3. The Holder must obtain a pre-assigned application number
4. All content submitted (whether as simple as the annual commitment letter or more complex submissions) must adhere to FDA file format types using eCTD specifications and FDA PDF specifications. There are additional FDA requirements in the case of more complex operations.
5. Letters of Authorization (LOAs): Will need to be in a specific section of the DMF.

3.1.8 Letters of Authorization

Letters of Authorization (LOAs) should be submitted in Section 1.4.1 of the DMF. The copy of the LOA that is sent by the DMF holder to the Authorized Party (company or individual authorized to incorporate the DMF by reference) should be placed in Section 1.4.2 (“Statement of Right of Reference”) within the Authorized Party’s application.

Holders of Submissions that cite Type III DMFs

1. Manage the risk of delays due to suppliers (holders of Type III DMFs) having deficiencies as they do not meet eCTD requirements by May 5, 2018.
2. Develop resources required to monitor supplier readiness.

CONCLUSION – THE CLOCK IS RUNNING

Both holders of Type III DMFs and companies holding submissions that reference Type III DMFs need to move now to prepare for this deadline. Contact Montesino (or the expert service of your choice) today to review these issues.

Finally, if you also hold a Canadian Type III DMF, contact us immediately! We will send additional information.