Preliminary Stages of eCTD Publishing and Electronic Filing
The eCTD publishing and electronic submission filing journey begins with these three steps:
- Contact the FDA Electronic Submission Support team via email (email@example.com) to inform them of your intent to submit an eCTD and request a sample number.
- Set up and test an Electronic Submissions Gateway (ESG) account via the FDA website. (FDA also provides a helpful checklist for setting up a WebTrader accountwith the ESG.)
- Submit a sample eCTD.
There are essentially just three viable options available to you when making the transition to an eCTD publishing, each dependent on what will work best given your individual business circumstances and resource availability. Each eCTD publishing option has various benefits and drawbacks.
- Do it all yourself and do all of the eCTD publishing in-house (which usually requires a larger up-front investment in an eCTD publishing-capable electronic document management solution [EDMS] but provides maximum value and control)
- Leverage an outsource partner to produce the compliant eCTD publishing submission output and submit the final eCTD on your behalf (which also usually involves the use of a commercial EDMS that facilitates the management of source eCTD publishing documentation via functionality, such as the automatic rendering of submission ready PDFs
- Use a standard, no-frills file system and then send source documentation to an eCTD publishing vendor to render, index, bookmark, and hyperlink each document and then publish the final eCTD for you
Typical Causes of eCTD Publishing and Filing Failures
Before fully engaging in eCTD publishing activities, it pays to be cognizant of the main reasons the FDA usually rejects eCTD submissions. At a recent RAPS meeting, the CDER Electronic Submission Support Team’s Jonathan Resnick outlined the following five reasons for eCTD publishing and filing failure:
- Duplicate submissions (an accident that applicants make all too easily if care is not taken when submitting via the ESG)
- Submitted to the wrong center (e.g., CDER instead of CBER)
- Mismatched application/sequence type
- Invalid file types (e.g., zip and exe)
- Not in standard eCTD publishing format (or missing key files such as us-regional.xml, index.xml, etc.)
An awareness of these commonplace problems—and the proper attention to detailed eCTD publishing and submissions requirements—can help companies avoid potential submission pitfalls.
Solutions for Streamlined eCTD Publishing and Complete Document Management
While the prospect of making the shift to eCTD publishing may terrify smaller pharmaceutical companies that are already struggling to compete, you can rest assured there are affordable options for versatile EDMS solutions that fit any size company and that scale to support continued growth as your organization grows.
MasterControl offers end-to-end eCTD document management via an unsurpassed preconfigured and scalable EDM/eCTD JumpStart configuration that is based on the DIA EDM Reference Model designed for eCTD publishing documentation management. The solution fosters a disciplined approach toward the authoring and review of submissions documents by facilitating the creation and eCTD publishing of submissions-ready documents. It is designed to meet the most rigorous document management and control standards enforced by regulatory reviewers.
With MasterControl’s eCTD publishing solution, users are able to generate submission-ready documents and control, track, and collect them within the system’s centralized, secure, and integrated electronic platform. The eCTD publishing solution enables virtual collaboration on submissions documentation and provides automated routing, escalation, approval, and revision control of documents. The validated MasterControl system can even use document property values to automatically populate eCTD publishing attributes (i.e., manufacturer, substance, product, study number, etc.). Any item that needs to be a part of the submission can be flagged within the system, making it easier to compile the final eCTD submission. Even when documents are revised at the last minute, an updated approved version is automatically exported to MasterControl. In addition, the electronic control and tracking of access share rights makes the eCTD publishing process more efficient and reduces any imposition on IT personnel. Through partnerships with industry-respected eCTD publishing tool vendors, such as Lorenz (docuBridge) and Extedo (eCTDmanage), MasterControl offers integrated eCTD publishing solutions that allow users to seamlessly manage the compilation of eCTD submissions content and publishing outputs.
Learn More about eCTD Publishing
To learn more about eCTD publishing or MasterControl’s eCTD publishing solutions, contact a MasterControl representative.