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Reg Ops Radar: eCTD & Regulatory Updates

May 14, 2024 | Featured, Life Sciences, Pharmaceutical and Cosmetics

Industry is currently seeing rapid changes and improvements to existing eCTD formats, requirements and suggested uses from FDA, among other changes that affect Regulatory Operations on a whole. Here at LexisNexis Reed Tech, we want to be sure that our customers are not only up-to-date with, but understand, these new developments. To support this knowledge share, our in-house team of eCTD experts will be tracking changes and offering insights on a regular cadence this summer.

Please find our weekly updates below and follow us on LinkedIn and X to be alerted of when this page is updated. For more information about our Reed Tech eCTD services, or have questions answered about your specific scenario, contact our team of experts.

Introduction of “Context of Use” in eCTD 4.0

May 21, 2024 – In the fast-evolving landscape of regulatory affairs, staying ahead requires not only compliance but also efficiency and precision. With this, the new eCTD v4.0 specification introduces an innovative concept called “context of use,” which marks a significant advancement in how we categorize and organize documents under the Common Technical Document (CTD) headings. Below, we have outlined some of the in which this differs from eCTD 3.2 and why it is beneficial to you, the end user.

Context of Use: A New Standard for Clarity

Context of use allows us to precisely categorize documents with associated keywords that provide a clear understanding of their relevance. For instance, a study report can be categorized under the appropriate CTD heading with keywords like “pharmacokinetics” and “healthy subjects.” This creates a hierarchical structure where documents are not just placed under broad categories but are tagged with specific descriptors that highlight their context.

Benefits of Standardization and Harmonization

For reviewers, this means enhanced navigation and efficiency. Instead of sifting through numerous documents to find relevant information, reviewers can quickly scan keywords and CTD headings to locate the exact documents they need. This approach drastically reduces the time and effort required to access pertinent information, allowing for more focused and effective reviews.

From the perspective of sponsors, the context of use approach enables a more consistent and harmonized organization of submissions. Documents can be categorized in a standardized way across different sequences and submissions, simplifying the document placement process.

This standardization not only makes it easier for sponsors to prepare submissions but also ensures that reviewers can quickly and reliably find the content they need.

Why eCTD v4.0 is an Improvement Over eCTD 3.2

The introduction of context of use in eCTD v4.0 addresses several limitations of the current eCTD 3.2 specs. In eCTD 3.2, the lack of precise categorization and keyword association often results in documents being harder to locate and review. Documents in eCTD 3.2 are not as clearly connected to their specific contexts within the CTD framework, leading to inefficiencies.

eCTD v4.0 enhances the review process by providing clear context for each document, enabling reviewers to access relevant information quickly and without sifting through irrelevant material. This significant improvement over eCTD 3.2 makes the review process more efficient and focused. Additionally, the “context of use” approach in eCTD v4.0 fosters consistency in document categorization across sequences and submissions, unlike eCTD 3.2, where inconsistencies can lead to confusion and inefficiency. This harmonization simplifies document placement and enhances the overall quality of submissions.

Embracing the Future

As the regulatory landscape continues to evolve, embracing advancements like eCTD v4.0 is crucial for maintaining efficiency and compliance. By leveraging the context of use approach, sponsors can ensure their submissions are organized and accessible, ultimately leading to more successful regulatory outcomes.

In summary, the context of use in eCTD v4.0 is not just a technical upgrade—it’s a strategic enhancement that brings clarity, efficiency and precision to regulatory submissions. As we move forward, adopting this innovative approach will be key to staying ahead in the ever-changing world of regulatory affairs.

Author: Adrian Alderfer, LexisNexis Reed Tech, and Wendy Scott, Reed Tech

eCTD Version 4.0 Release

May 14, 2024 – The electronic Common Technical Document (eCTD) format is evolving with the release of version 4.0. One key change is the introduction of a dynamic single submission unit message that encompasses both ICH (International Council for Harmonisation) and regional content, including study data.

Previous versions of eCTD utilized separate submission units for ICH and regional content. For example, the eCTD v3.2.2 specification outlined modules for the ICH Common Technical Document (CTD) as well as additional regional submission units. But with eCTD 4.0, there is now a consolidated approach that combines these into a single submission unit message.

This unified submission unit message improves accessibility and navigation for reviewers. By bringing together ICH and regional information into one submission unit, reviewers can more easily find and connect related content. For instance, a reviewer could quickly navigate from a study report to related data within the same submission unit, rather than having to search across multiple units.

The single submission unit also allows for more flexible lifecycle management of the eCTD. Content modules can be reused or replaced as needed across submissions. Sponsors can manage and maintain a “single source of truth” for submission documents. This reduces duplication and inconsistencies compared to managing separate ICH and regional submission units.

According to the eCTD 4.0 guidance, the consolidated unit simplifies submission organization and structure. Files and documents are packaged together, with all relevant content in one place. This streamlined approach replaces the need to compile separate regional submission units. It also improves context for reviewers, with all information presented in a unified sequence.

Sponsors preparing eCTD 4.0 submissions should familiarize themselves with constructing this new consolidated submission unit message. With some restructuring, it can improve the clarity and consistency of submissions, benefiting both sponsors and reviewers. The single submission unit is just one example of how eCTD 4.0 aims to enhance standards for electronic regulatory submissions.

Author: Adrian Alderfer, LexisNexis Reed Tech

Reference: ICH. (2020). Electronic Common Technical Document (eCTD) v4.0. Retrieved from

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