By Mary Waters

The FDA had a mandate for submitting in eCTD format Drug Master Files (DMFs) (other than Type III – packaging material). Luckily for some, there was a reprieve as the FDA extended that date another year until 05 May 2019. That said, there are still other submissions types that now need to be submitted in eCTD.

Submission Types Required in eCTD Format

In section 745A(a) of the Food, Drug, & Cosmetic Act (FD&C Act), Congress granted explicit authorization to FDA to implement the statutory electronic submission requirements. This section also applies to all subsequent submissions, including amendments, supplements, and reports, to the submission types identified below:

  • New Drug Applications (NDA)
  • Abbreviated New Drug Applications (ANDA)
  • Biologics License Applications (BLA)
  • Commercial Investigational New Drug (IND) applications
  • Master files, such as DMFs

Implications for NOT using eCTD

Submissions not in electronic format(s) as described in the FDA guidance document will NOT be filed or received unless exempted from the electronic submission requirements (e.g., investigator-sponsored INDs: emergency use INDs and treatment INDs).

Electronic Submission Specifications and More

OMG, where to start…

  • Obtain a pre-assigned application number from the appropriate FDA Center.
  • Must follow the FDA eCTD technical specifications.
  • Must place each file in the appropriate main folder (m1 through m5) as well as the appropriate subfolder.
  • Must use the correct nomenclature for file names (only letters, numbers, hyphens or underscores), n-t-e 150 characters. No empty folders or subfolder are allowed.
  • Must use current portable document format (PDF) and version; documents must be submission-ready. FYI – PDF files have extensive rules to follow and validation criteria to pass.
  • Must use correct document lifecycle operator (new, replace, delete).
  • Clinical Efficacy and Safety Reports much adhere to the rules outlined in the guidance.
  • Datasets and Study Tagging Files (STF) are required when providing information in m4 or m5. STF are required for each study and are required for documents such as adverse event reports or change in principal investigators (PIs).
  • Submissions 10 gigs (GB) and under must use the ESG.
  • Submissions must include only FDA fillable forms, e.g., 1571 or 356h as well as an electronic signature to enable automated processing. Note: scanned images of the forms will not be accepted (i.e. rejected).
  • Don’t submit paper unless requested, e.g., meeting / briefing materials.
  • The FDA calculates the “receipt” date only after the submission has been through technical validation. The FDA sends an initial receipt and then two acknowledgments to the sender.

If you answer “yes” to any of these questions below, you may need us…

Is all of this information too much to digest or comprehend? Are you feeling overwhelmed with all of the steps involved in setting up a compliant system? Have you been designated the “IT” guru and really don’t want that title/responsibility? Do you have a submission or even several that need to be at the FDA in a matter of days and haven’t even started the process?

If you’ve answered YES to any of the above questions, it’s time to git’er-done! HartmannWillner is your answer forgetting, and then staying compliant with the FDA (and not missing deadlines).

Feel free to reach out to us so that we can help you! We’re just an email away!

References

FDA Guidance for Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM333969.pdf

FDA Electronic Common Technical Document (eCTD) https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/ucm153574.htm

 

 

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Nitisha Pyndiah - Biotech Consulting Services

Mary is an expert provider of electronic Common Technical Documents  (eCTD) publishing services. Since joining HW in 2016, Mary has submitted over 225 electronic submissions through the FDA ESG.