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FDA to Require Pharmaceutical Applications to be Submitted Electronically

On May 5, 2015, the U.S. Food and Drug Administration (FDA) published a final guidance document requiring certain pharmaceutical product applications to be submitted in Electronic Common Technical Document (eCTD) format.  FDA will require electronic submissions of the following applications:

  • Certain investigational new drug applications (INDs)
  • New drug applications (NDAs)
  • Abbreviated new drug applications (ANDAs)
  • Certain biologics license applications (BLAs)

The guidance also applies to amendments, supplements, and reports to the aforementioned applications. Drug master files (DMFs) and biological product files (BPFs) are included, as FDA considers them supplemental to the applications.

Most submissions must be submitted in eCTD format by May 5, 2017, with the exception of INDs, which must be submitted in eCTD format by May 5, 2018. Noncommercial INDs are exempt.  This includes amendments, supplements, and reports to previously existing submissions.   Applications and updates not submitted in electronic format will not be filed or received by FDA.

eCTD submissions are faster to submit and easier to manage and edit than paper submissions.  Converting existing DMFs to eCTD format can make the updating process easier for when the requirement begins.  Registrar Corp can help pharmaceutical companies submit or amend a DMF, file an annual report, or convert a paper DMF to eCTD format.

For questions about the upcoming eCTD submission requirement or other FDA regulations for pharmaceutical companies, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.





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