GLOBAL
July 25, 2024
3 min
The electronic CommonTechnical Document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER). Creating a comprehensive submission plan requires expertise, adherence to guidance, and familiarity with best practices. In this blog, we will explore tips and insights for successful eCTD submissions. Whether you’re a regulatory affairs professional or looking for qualified publishing vendors, these tips are designed to help you navigate the complexities of the eCTD regulatory landscape effectively.
Employ the services of a well-versed submission project manager, preferably one with industry experience. Every product has its nuances, and these nuances can bear critical impacts to the synchronization of eCTD modules, the timeline, and the budget if they are not understood, identified, and de-risked. For example, a submission project manager with analytical industry experience will understand that if the sponsor’s CMO is developing a new method for biological activity, delays may arise. Most likely, the IND data for GMP lots will be delayed; the experienced submission project manager will know which CTD module 3 sections will be impacted, will understand that these sections will have to be framed out with placeholders or unapproved data, and will initiate an action item to circle back and verify the draft data against an approved COA. This intrinsic submission knowledge is not something taught during project management training.
Time is of the essence in regulatory submissions. Submission project managers streamline workflows and integrate robust quality assurance measures into the submission timeline, ensuring that eCTD submissions are not only accurate but also delivered on schedule. By prioritizing precision to minimize the risk of delays and rejections, submission project managers keep your regulatory timelines on track. Simply put, they hold the pieces together!
While in-house publishing may seem like an efficient solution for managing submissions, there are several reasons why sponsor companies would consider partnering with an eCTD publishing vendor instead. First and foremost, sponsors can optimize their publishing processes by leveraging the vendor’s in-depth knowledge of regulatory submissions. For smaller companies with a young portfolio, in-house publishers will rely on experience and regulatory intelligence to build out processes. Vendors who specialize in publishing will leverage lessons learned from other submissions in real-time to help guide your team on the best submission strategy in the current regulatory landscape.
Furthermore, engaging a vendor can offer significant cost savings and efficiencies. Building and maintaining an in-house publishing infrastructure can be resource-intensive, requiring software and training investments. By working with a vendor, sponsors can optimize their budgets by utilizing the vendor’s high-cost publishing software on an as-needed basis, reducing overhead costs.
In addition to technical expertise and cost considerations, partnering with an eCTD publishing vendor can enhance the overall speed and agility of the submission process. Vendors with dedicated publishing teams can expedite the compilation, validation, and publishing of eCTD submissions, helping sponsors meet critical timelines and milestones. This accelerated turnaround time can be pivotal in gaining regulatory approvals and maintaining competitive market positioning.
Be sure to select a publishing vendor who stays current with publishing tools and requirements to avoid rejection of your submission. Local regulations change frequently and vary from region to region. For instance, in CTD Module 4, SEND data is required. Often the SEND data you receive from a vendor is NOT exactly what is required. An experienced publisher will know which requirements are critically important; should you not follow the Technical Conformance Guide (TCG) provided by the FDA, you could be rejected for adding documents that are not needed OR not including documents that are needed. For example, many clients receive (within their SEND data) an ‘’nsrdg’’ document which helps the FDA reviewer. If you go back to the vendor for this, this could add time and delays when based on the TCG, it’s a recommendation not a requirement.
When it comes to eCTDsubmissions, what may seem like “small mistakes” can be cumbersome for the submission lifecycle. Non-compliance with eCTD standards can increase the likelihood of Information Requests (IR) and puts sponsors at risk of validation errors or submission rejection. Below are common validation errors identified and resolved during the copyediting and formatting review process, mitigating the associated corrective actions that FDA could require.
External Links: If external links are identified in documents, edits will be required to ensure that external links are removed for future submissions.
Invalid Formatting: Invalid formatting in an eCTD submission could range from including a document under an invalid heading or module, mislabeling files, using invalid characters in file names, to file corruption. Depending on the severity of the formatting issue, sponsors may be required to resubmit the file with corrections, edit the document in a future submission to ensure compliance with proper formatting, respond to an IR, or modify their SOPs.
Missing Documents: The corrective action may vary based on the missing document. Sponsors may be required to resubmit the missing file with a new submission sequence, respond to an IR, or provide the document in a future submission.
Missing Text: Similar to missing documents, there is a range of corrective actions based on the text omitted. FDA may open a query to ensure the required information is included in a future submission, issue an IR, or require a resubmission.
Broken Links and Bookmarks: Edits will be required to ensure that links and bookmarks are corrected in a future submission. If the reviewer is not able to find the referenced section or source in the submission, FDA may issue an IR. Edits will be required to ensure that links and bookmarks are corrected in a future submission. If the reviewer is not able to find the referenced section or source in the submission, FDA may issue an IR.
Despite thorough copyediting and formatting efforts, oversights can happen, and technical issues can occur during the finalization process (e.g., file corruption or excessive file size). It is imperative that publishers use software to identify validation errors and integrate ever-changing eCTD regulations in real time before the application is submitted to regulatory authorities.
Comprehensive programs streamline and simplify the publishing process by eliminating unnecessary steps and prevent rejection errors. While the most critical function of eCTD software should be its ability to accurately identify validation errors, high-quality publishing tools offer more than just this functionality. A strong technology infrastructure supports seamless collaboration and real-time tracking, giving sponsors full visibility into the progress of their submissions. By utilizing state-of-the-art eCTD publishing tools and software, publishers enhance efficiency and accuracy while maintaining the highest standards of data security.
Using cutting-edge technology is an investment that pays off in terms of efficiency, reduced errors, and smoother submission and review processes. However, publishing software cannot replace regulatory writing best practices and comprehensive submission strategies. Ultimately, it is the expertise and diligence of the project team that drives the quality of the submission.
Are you ready to streamline your eCTD publishing process and achieve regulatory success with confidence?
With a track record of excellence and a commitment to providing superior services, Global Regulatory Writing & Consulting (GLOBAL) has established itself as a trusted partner for efficient and reliable eCTD publishing solutions. Whether you are preparing your first submission or seeking to optimize your existing processes, we offer customized solutions that align with your specific requirements. From document preparation and formatting to submission compilation and lifecycle management, our Regulatory Operations Team handles it all with meticulous attention to detail. Your success is our success and we are committed to delivering exceptional service and results that exceed your expectations.
Let's Partner for Success:
Contact us today to discuss how GLOBAL can support your eCTD publishing requirements. Together, we’ll navigate the regulatory landscape with confidence, ensuring your submissions stand out for all the right reasons.
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