IND in eCTD Format, Paper to eCTD Submissions as per USFDA

An Investigational New Drug (IND) sponsored by a corporate entity is considered as a ‘Commercial IND.’ Center for Drug Evaluation and Research (CDER) has the authorization to designate IND as commercial if it finds the intent to commercialize the drug in future. In the United States, INDs must be registered with the Food and Drug Administration (FDA). As part of the implementation of FDA’s final notification released on May 5th, 2015 regarding adaption of eCTD formats, Commercial INDs are required to be submitted in eCTD format by May 5, 2018.

With the phase 1 of eCTD submissions completed, the FDA has already stopped accepting paper format for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs) from May 5th, 2017. Under phase II, Commercial INDs along with Drug Master Files (DMFs) are required for eCTD submissions. As the countdown for submissions in eCTD format is coming to an end, here are some of the possible approaches we laid out for conversion of Commercial INDs.

Approach 1 - Direct change over to eCTD format

  • Since FDA does not insist to resubmit all the information of an IND that was previously submitted in paper format, sponsors can plan for direct change over to eCTD format for the subsequent submissions/amendments that are planned after 5th May 2018 for an already submitted IND.
  • In this case, the applicant may require to re-submit the previously submitted (paper submission) data that might have referred in the new submission (amendment) in eCTD format to facilitate instant access for FDA reviewer.
  • However, this approach may not be an ideal way for INDs with multiple amendments as the re-submission of reference data every time from previous submissions will be a difficult job for sponsors.

Approach 2 - Preparation of Baseline IND submission

  • Even though FDA does not insist to resubmit all the information (in eCTD) that was previously submitted in paper format, a baseline submission is an ideal way to switchover from paper submissions to eCTD. This is because changes to investigational drug require referring the data from previous submissions every time a new amendment is submitted. Regulatory review without a baseline submission will be a daunting task for FDA reviewers as they would need to request for old paper submissions from the archives to refer to the information from previous submissions.
  • In this approach, an applicant can create a data tracker in the first step. This data tracker will help in identifying the current (live information) from already submitted paper submissions (initial submissions & amendments). In the next step, the applicant can prepare a baseline IND by compiling the current information from previous submissions into Baseline IND with the help of the data tracker.

Enroute, the Sponsors must engage utmost care while laying out all related documents and files in eCTD format. Cataloguing, filing, naming and structuring, must be accurate to stay within the specified format while converting. Given the multiplicity involved, and fast-approaching deadline for commercial INDs, assistance by an experienced submission partner is advised. Sponsors can expedite the conversion process availing an effective publishing and submission software tool.

Apart from Commercial INDs, DMF holders must also be aligned with the USFDA’s eCTD deadline, May 5, 2018. How prepared are you? Get a quick support