eCTD submission Regulatory

Form 3938: New FDA form for Drug Master File (DMF) Submissions

A meeting has been held by US-Food & Drug Administration for explaining the concept of new FDA form 3938 for the submission of Drug Master File to FDA. The agenda for the meeting was to explain the concept of Form 3938, the details of the form, purpose of the form, when should the form 3938 be used and who can use this form. Also a live walkthrough was arranged by the Subject matter expert in order to guide the audience about the details to be furnished in the form.

Form 3938 is an electronic application form designed specifically to submit DMF by US-FDA. It is to be used by the DMF holder, the U.S. agent and a 3rd Party contractor for the submission of DMF. It was mentioned in the meeting that this form should accompany all DMF submissions submitted in the eCTD format (except Type III DMF as it is an exempt from the eCTD requirement. The purpose of this amendment is to:

  • Provide a standardized fillable electronic form for Drug Master File (DMF) submissions
  • Allow for automated pull of DMF information into FDA databases
  • Capture relevant DMF submission information submitted using the electronic Common Technical Document (eCTD) format.

It was clearly specified that this form can be sign by either the Responsible Official at the DMF Holder Company or the Appointed DMF Agent can sign DMF Form 3938. It is also acceptable for another employee to sign on behalf a company’s Responsible Official as long as the signed form reflects the Responsible Official’s name in Field 11. It was also mentioned that a third party (contracted company) cannot sign the DMF form 3938. Also the DMF holder can only be a single person or entity. If the DMF holder is not the manufacturer, the DMF holder should include a signed statement in their original submission that the DMF holder assumes full responsibility for the manufacturing of the Subject of the DMF. Moreover, there is no need to request for a new DMF number for existing application while converting from paper to eCTD. But the applicant should take in to account that the application number should be of 6 digits and if the number is not of 6 digits then the application number should be prefixed by the number “0” to make it a six digit number. (For e.g. if the application number is “1234” then it should be updates as “001234”).ss

Few other rules were declared in the form 3938 which must be considered while submission. In the form there is a column for Fax number, so fax number should be mentioned in the section and if the section number is available then it should not be left empty but “not available” should be mentioned in the appropriate field on the form. If not done so an error message will be displayed. Similarly, in the “FEI number or a DUNS number” column an entry has to be done in order to avoid an error in the form. If those numbers are not available, then enter “9999999999” (10 digits) in the assigned field to finalize the form.

It was disclosed in the meeting that this form is currently under review and approval process at FDA and Office of Management and Budget (OMB) and hence it will be available for industrial use in the early months of 2021.

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