As the pharmaceutical industry continues to evolve, so too do the processes for regulatory submissions. One significant development is the introduction of eCTD (Electronic Common Technical Document) 4.0 (read this blog to get a primer on eCTD if you’re not familiar with it). This latest iteration promises to overhaul the way pharmaceutical companies submit their drug development data to health authorities. In this blog post, we will explore the top 10 things you need to know about eCTD 4.0 and its potential benefits for the industry.
1. An Advancement in Electronic Submissions
eCTD 4.0 advances the capabilities of electronic submissions for regulatory purposes. It builds upon the success of previous eCTD versions (using familiar headings and hierarchy) but introduces the framework for increased structured information that aims to streamline the submission process, making the transfer of data to health authorities more efficient and standardized.
2. Enhanced Submission Quality
One of the key features of eCTD 4.0 is its focus on ensuring submission quality and efficiency. The latest version incorporates extensive validation rules that help publishers identify and correct errors before submissions are sent to regulatory agencies. This ensures that submissions meet the necessary standards and guidelines, reducing the likelihood of rejection or delays.
3. Increased Global Harmonization
With the global nature of the pharmaceutical industry, collective standardization of submissions across regulatory authorities is crucial to a sponsor’s ability to seek approval for a product in multiple regions. The adoption of eCTD 4.0 will continue moving the industry toward global harmonization with multiple major health agencies already outlining timelines, technical specifications, and validation rules for the implementation of this latest eCTD version.
4. User-Friendly Lifecycle Management
eCTD 4.0 improves the product lifecycle management process within regulatory applications. It provides the ability to replace one document leaf with many in the same context group or vice versa. It also allows sponsors to update keywords when adjustments or corrections are needed which will mitigate some of the current obstacles encountered when amending previously submitted information in an eCTD application.
5. Embracing Structured Data
Structured data is at the very core of eCTD 4.0. This version promotes the use of controlled vocabularies and standardized data formats, which will enhance data consistency, further facilitate the transfer of this information, and streamline its analysis by regulatory authorities.
6. Changing Terminology
Submission unit, keywords, context groups…these are all terms that regulatory professionals will need to familiarize themselves with quickly for producing eCTD 4.0 submissions. While general terms such as module and sequence will remain the same, other terms typically used when referring to parts of an eCTD submission have been modified in the guidance to describe their role more accurately in the eCTD format.
7. Improvements on the Past
The ability to submit in an electronic format revolutionized the regulatory submission process which had previously used paper submissions. eCTD 4.0 builds on this success with the familiar modules of previous eCTD versions but incorporates changes to further streamline this process. Unlike version 3.2.2, eCTD 4.0 only requires creating a single XML to submit a sequence to the FDA instead of separate XMLs for regional and study tagging file content. It also refines the requisite structure and metadata with shorter file folder lengths and enhanced keyword capabilities.
8. Compliance with Regulatory Requirements
eCTD 4.0 aligns with the latest regulatory requirements and will swiftly become the standard with many health agencies mandating implementation within the next six years. Some agencies have already completed the pilot stage and are moving toward the voluntary implementation phase. The US FDA will require applications to be submitted in eCTD 4.0 format by 2029, however, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will make this format mandatory as early as 2026.
9. Faster Review and Approval Processes
By streamlining the submission process and improving data quality, eCTD 4.0 can accelerate the regulatory review and approval of drug applications. Faster approvals mean pharmaceutical companies can bring their products to market more efficiently, benefiting patients and boosting business prospects.
10. Avoids Resubmission of Content
When it is time to transition existing applications from eCTD v3.2.2 to v4.0, forward capability will be possible, and it won’t be necessary to re-submit previous content. In the same vein, documents submitted in eCTD 4.0 applications will not need to be re-submitted to the same authority if referenced in a new application. Each submitted element of an eCTD 4.0 submission, including documents, will have a universally unique identifier (UUID) that can be referenced in a new application without including the physical file.
Conclusion
eCTD 4.0 is a significant step forward in the world of electronic regulatory submissions for pharmaceutical companies. It builds on the successful foundations of previous eCTD versions while refining the format and enhancing its capabilities. By embracing this improved format, sponsors can increase the likelihood of their application’s approval, expedite the review process, and ultimately reduce delays in bringing their products to the global market.
When it comes to preparing your transition to eCTD 4.0 submissions, you should work with RegOps experts. At Certara, we can help you simplify your regulatory processes and assure submission success with our GlobalSubmit eCTD software and Certara Regulatory Operations and eCTD Publishing specialists.