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Key Considerations for the Upcoming Mandatory eCTD Requirement

April 27, 2017 | Kathy Elks, Principal Consultant and Jeff Golden, Associate Director | Regulatory Operations

People who work in Regulatory Affairs, and especially those in Regulatory Operations, are well aware of the fact that it is less than a month before eCTD submissions will become mandatory. Starting on May 5th, all NDAs, ANDAs, and BLAs that are submitted to the FDA must be filed in eCTD format.

Many companies have already transitioned to eCTD submissions. However, for those companies that have not transitioned to eCTD submissions, we have some things to keep in mind regarding the requirement.

Update

First and foremost, there has been a recent change that we want to bring to your attention! Earlier this month, FDA issued Revision 4 to the guidance, which allows an extension for master files. (This is why we didn’t mention master files in the previous section.)

The update has extended the timetable for master files from 24 months to 36 months. This means that master files will not become mandatory for eCTD submissions until May 5, 2018. However, we recommend to companies that submit master files to start planning now in order to stay ahead of the curve.

Image courtesy of Stuart Miles at FreeDigitalPhotos.net

Clarification…

Image by Master isolated images at FreeDigitalPhotos.net

One question that we want to clarify from the start, which several clients have asked, is: “Do we need to resubmit our entire NDA in eCTD format?” The answer is NO.

For established NDAs, ANDAs, and BLAs, you only need to submit your future supplements or amendments in eCTD format. You can imagine our horror when one sponsor called and asked if we could help them scan their entire NDA for a decades-old application! We quickly shared the news that they did not have to resubmit the application.

Ok, now on to the heart of this post…

Key Points When Transitioning to eCTD Submissions

There are several key points to keep in mind as you plan the transition to eCTD submissions. We frequently are asked by start-up companies and small companies for help as they transition to eCTD. We have provided a few key points that you need to be aware of, or should consider, when making the transition.

1. eCTD Publishing Software

In order to create an eCTD submission, you must have software. There are many developers/vendors of eCTD software. Vendors offer software as a service (SaaS) options for companies that do not want to install, validate, and maintain software on their own network.

Whichever option you choose, you will also need trained staff to use the software who also need to understand the principles of eCTD publishing and lifecycle management.

2. FDA Fillable Forms

With the mandatory eCTD requirement, companies must use FDA fillable forms in their submission. In the paper world it didn’t matter if you used a fillable form but now it is mandatory. Upon completion of the form, the form must be signed using a digital signature. The old days of printing, signing, and scanning the form are obsolete. While there are many technologies for signing the form, the FDA is fine with a flattened digital signature which is easy to implement using Adobe.

3. Templates and Granularity

One of the biggest challenges in transitioning to eCTD is the structure and layout of the documents that are within a submission. It is imperative that companies use templates when creating their documents. Using eCTD templates will ensure the granularity required by the FDA. The documents in an eCTD submission must be in the correct granularity and follow FDA’s Comprehensive Table of Contents Headings and Hierarchy.

The first step in migrating to eCTD submissions begins with the document authoring process. As a specific example, using templates in the correct granularity and layout is most important for the CMC sections, since these sections can be quite granular.

There are many vendors that market eCTD templates. A quick Google Search will help you locate several template providers.

4. Electronic Submission Gateway

Prior to mandatory eCTD submissions, companies could copy their submission to digital media (ie, compact disc, thumb drive) and mail the package to the FDA. Beginning in May, companies must use the Electronic Submission Gateway (ESG) when sending their submissions to the FDA.

It takes a few weeks to secure an account. FDA has a detailed step-by-step guide that outlines the steps for obtaining an account. Or you can check out our previous blog post “Eight Easy Steps to Establish an ESG Account with the FDA” that you may also find very useful.

5. Viewing Software

Once an eCTD submission is published, you will need viewing software. Typically referred to as a “Viewer” this software provides a way for your team to easily review, QC, and approve eCTD submissions. This is an important step that should be done before an application is sent to the FDA.

A Viewer is an excellent way to see an entire application. A Viewer is especially useful when you need to view your application during phone calls with the FDA or when sharing information with potential partners during Due Diligence activities.

Viewers are commercially available. Having worked at several companies that did not have a Viewer, we cannot overstate the importance of deploying a Viewer within your company. Check out our previous post entitled “Electronic Submissions for Paper People” for some details on commercially available Viewers.

Need Help?

Transitioning to eCTD doesn’t have to be a cumbersome process. As with many things in life, planning is one of the most important elements. Make sure your transition team includes all of the key members. Besides Regulatory Affairs and Operations, remember to include the authors from each discipline, scientists, and project planners. It is critical that your management team is fully committed to this effort!

If your company doesn’t have the resources to make the transition alone, please contact us or give us a call. We have helped numerous companies make the transition from paper to eCTD submissions. We specialize in this process and will be happy to assist you.

Category: Regulatory Operations
Keywords: eCTD, eCTD Viewer, ESG, Templates

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