FDA – December 2015 eSubmission Guidances – The Clock Starts

By 3. February 2015Blog

FDA announced already at the beginning of 2008 that eCTD was the preferred format for electronic submissions. We know that 80% of NDA submissions and 95% of ANDA submissions are already made to FDA in the eCTD format. Industry uptake has been good considering that eCTD is still not mandatory.

We are waiting for the final issuance of the FDA Draft Guidance from July 2014 “Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions using the eCTD Specifications”. This final guidance is expected to represent the clock start for the mandatory use of the eCTD format for most applications.

So what is happening now?

The latest guidance issued in December 2014 (Providing Regulatory Submissions in Electronic Format – Submissions Under Section 745A(a) of the Federal FDA Act) means that instead of one giant leap for FDA and industry alike, what we will continue to see is a step-wise approach toward implementation of the eCTD requirements.

In the new guidance, FDA states, “it is not feasible to describe and implement the electronic format(s) that would apply to all of the submissions covered by section 745A(a) in one guidance document.” Multiple guidances related to specific parts of the eCTD will be finalized before we see the full-scale implementation for the various application types.

While it would have been useful for FDA to issue a similar document to the EMA Submissions Roadmap that was published in November 2014, this did not happen. Interestingly, the 2015 CDER Guidance Agenda includes only two guidances planned that are related to eSubmissions . Neither of these is what I would call the BIG ONE. The real drop-dead dates still loom uncertain.

With no final dates for implementation in the various application types, the new guidance still highlights change scenarios and the corresponding timelines for implementation:

  • Major revisions and updates to existing formats – 24 months
  • Minor changes to required format – immediately/shortly
  • New format – 24 – 36 months
  • Update to required format – less than 24 months
  • Correction to required format – less than 24 months

This means that sometimes eCTD software updates will need to be almost instantaneous. True cloud based software providers will have the advantage over their on-site competitors when it comes to implementing new requirements or changing existing ones.

The second guidance issued in December 2014 entitled “Providing Regulatory Submission in Electronic Format – Standardized Study Data” applies to nonclinical and clinical data that is submitted to support applications. The guidance represents exactly the step-wise approach that FDA has outlined for eSubmissions in the guidance that was just discussed.

The guidance states that the study data must be submitted in a format that FDA can process, review and archive. They leave the final choice to the sponsor of which standards in the Data Standards Catalog to use. FDA will use a transition date approach to implement changes or new standards to the Standardized Study Data requirement.

In short, what we are seeing here is FDA’s consensus that all eCTD requirements cannot be covered by a single guidance. By separating out some requirements and issuing them more quickly, we will move closer to full eCTD submissions. At any rate, industry needs to be flexible and quick to adapt as we move forward.

From both industry and regulator standpoints, eCTD is still in its infancy. All of us took baby steps before we began to run and it looks like mandatory eCTD implementation will be the same.