FDA eCTD Mandate: One Year and Counting

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Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the same.

Here we are in 2016, and, to the surprise of some and the consternation of many, paper applications are still alive and well. However, their days are numbered, with FDA’s eCTD mandate for certain application types set to take effect one year from today.

What’s Changed?

Back in 2011, FDA processed just over 1 million submissions through the Electronic Submissions Gateway (ESG). At that time, FDA’s Center for Drug Evaluation and Research (CDER) also reported that almost 70% of new NDAs and 41% of new INDs were submitted in eCTD format. Contrast that with the data from 2015 (the most recent, full-year data available). Last year, 3.1 million submissions were processed through the ESG, with 100% of new NDAs and just over 80% of new INDs submitted to CDER in eCTD format.

FDA eCTD Mandate

Source: DIA Regulatory Submissions, Information, and Document Management Forum 2016, Electronic Submissions Update, Ginny Hussong, Director of Data Management Services and Solutions, CDER, North Bethesda, MD, February 8, 2016

Clearly, eCTD has been embraced by industry over the last five years, and the eCTD mandate is evidence that FDA is “all in” as well. In fact, FDA expects that the number of submissions via the ESG will jump to 7 million in 2016, at least in part because of companies racing to convert remaining paper applications to eCTD.

Obviously, the biggest change since 2011 is the inauguration of the eCTD mandate itself. On May 2017, all ANDA, BLA, NDA, and Master File submissions to FDA must be filed in eCTD format, while commercial INDs get a reprieve until May 5, 2018. The requirement is stipulated in the binding guidance document Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

For certain application types, other regulatory authorities are moving even faster. Master Files, for example, are required to be submitted in submitted in eCTD format as of March 31, 2016 for Health Canada and July 1, 2016 for the European Medicines Agency (EMA).

What’s Stayed the Same?

Thankfully, the process for converting a paper application over to eCTD remains largely unchanged. Generally, it’s as simple as submitting an eCTD sequence to serve as the anchor for all future submissions. From then on, all future submissions must be made in eCTD format. FDA still does not require you to resubmit any information previously submitted in paper; however, in certain circumstances you may find it beneficial to resubmit such information in eCTD for the convenience of the FDA reviewer.

Take Action to Meet the Mandate

For companies who have not yet made the switch to eCTD, it’s time to take action. Whether you intend to prepare eCTD submissions in-house or plan to outsource them, the next twelve months will go by faster than you expect. It’s important that you begin to investigate solutions immediately. You want to have a solution in place well in advance of the mandate and avoid an awkward conversation with your board of directors about why you’re not able to file that application as planned.

If bringing eCTD publishing in house is your choice, you’ll need to consider several things. You’ll need appropriately trained staff on the payroll, and you’ll need eCTD publishing software. The time it takes to implement, validate, and train is also a major commitment. Finally, you’ll need to consider broader, organizational changes, such as drafting new SOPs, training your authors to create eCTD submission-ready documents, and making use of eCTD templates and authoring tools.

If an outsourced eCTD submission model is more practical, you’ll need to develop an RFP and solicit proposals from qualified vendors. The evaluation and selection process for outsourcing partners can be just as time consuming as that for purchasing software. You’ll want the time to move deliberately to ensure that you select a vendor with the right mix of technical competency, customer service, and cultural fit with your organization. Even if you plan to outsource, you will still also need to invest time and resources in things like new or revised SOPs and training for your team.


Author: Evan Richardson

Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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