Jan 09 2013

FDA's Updated Guidance Outlines Timelines for Mandatory eCTD Submissions

Coming Soon!

Image via p22earl @ Flickr

On 03 January 2013, FDA released a draft revision to the Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.

The most significant update in this revision is information on FDA’s timeline for making eCTD submissions mandatory.  In the recent FDASIA legislation, Congress authorized FDA to require electronic submissions, and this guidance is FDA’s first step in executing this authorization.

According to the draft guidance, marketing applications – ANDAs, BLAs, and NDAs – will be required in eCTD format 24 months after the final version of this guidance is released.  INDs will be required in eCTD format 36 months after the publication of the final version of the guidance.

The Federal Register notice states that the comment period for the draft guidance ends on 04 March 2013, so it’s likely that the final version of the guidance will be published in the second half of 2013.  Therefore, we can expect for these mandates to take effect along these lines:

  • Marketing applications – Late 2015
  • INDs – Late 2016

This should serve as yet another reminder for those who are still submitting in paper that it is time to make the switch to eCTD submissions.  Transitioning your procedures, personnel, and infrastructure to eCTD publishing can be a significant investment of time and money, so it would be wise to begin this transition now, well before the mandate takes effect.

The guidance also includes many other updates, but these are predominantly expansions or clarifications of information in the June 2008 version, rather than significant changes to the ways in which you should be preparing eCTD submissions.  I encourage everyone to read through the entire guidance to ensure that you are preparing compliant, reviewer friendly submissions.