Updated: May 19, 2020
Over the past few weeks, FDA has released several updates to critical guidance documents surrounding the topic of eCTD format. In this blog post, we will highlight the main takeaways that should resonate with Regulatory Professionals.
eCTD Guidance for Industry Version 7.0
On February 21st, 2020, FDA finalized the guidance “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications: Guidance for Industry (Revision 7)” after publishing a draft update in July 2019. The primary updates were centered around clarifying the qualifications for waivers and exemptions from eCTD format.
Most notably, it established that all non-Commercial INDs and Type III DMFs are exempt from eCTD format. Non-Commercial INDs are defined as applications that are not intended for commercial use, such as investigator-sponsors or research INDs. Type III DMFs are applications that serve to provide information on packaging materials in support of NDAs, ANDAs, or BLAs. FDA has been pushing back the eCTD deadline for Type III DMFs for several years in response to concerns expressed in industry comments, and with Revision 7 of this guidance, we now have clarity that these submissions will be permanently exempt.
As you may recall, in October 2019, FDA revised their guidance on DMF submissions for the first time since 1989. Check out WAYS’ previous blog post on the topic to learn more.
In addition to these exemptions, the guidance also clarifies scenarios where submissions can potentially be granted long-term or short-term waivers from eCTD format. The table below highlights the submissions types that could fall into each category.
Draft Guidance on Alternative Electronic Format
Closely following the release of Revision 7 of the eCTD Guidance, on March 10th, 2020, FDA released the Draft Guidance “Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry”. This brief, 7-page draft guidance provides clarity on how to compile a submission that has been granted an exemption or waiver to eCTD format. Overall, many of the PDF specifications, linking and bookmark requirements, and folder structures are consistent with what is required for eCTD format. However, any XML backbones that require a specialized software to be generated do not need to be included.
While this format will allow for sponsors to create the output on their own, it is important to note that compiling a submission and creating links between documents is a dynamic and time-consuming process that requires adequate planning. Also, per the guidance, submissions in this format are still to be submitted via the Electronic Submissions Gateway (ESG), so sponsors should ensure they are set up to use this interface. WAYS is happy to assist with any questions or need for support in creating a submission in this format.
Open commenting for eCTD 4.0
Finally, on February 27th, 2020, FDA opened two documents for public comment regarding eCTD version 4.0 – the draft “Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide” and draft “FDA eCTD v4.0 Module 1 Implementation Package.” Please note that these guides are not for implementation, FDA clarifies that only eCTD 3.2.2 will be accepted until version 4.0 is finalized. Per the Federal Register Notice, FDA is seeking comments “for the accuracy, suitability, and appropriateness of these specifications for the submission of eCTD v4.0 submissions”. Comments are being accepted until April 9, 2020 and can be submitted electronically or in writing. See this website for instructions on submitting comments.