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.

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Embracing eCTD v4.0

Things to Consider While Navigating the Transition from eCTD 3.2.2 to eCTD 4.0

Document Titles: Precision in Content Identification

Descriptive Submission Unit Titles Guide Reviewers

Application References: Cross-Referencing for Clarity

Ensuring Proper Submission Classification

Seamless Transition with Forward Compatibility

Maximizing Efficiency Through Document Reuse in eCTD v4.0

Streamline Document Lifecycle Management with Improved Context Groups in eCTD v4.0

Transition from Attributes and Values to Keywords

Introduction of “Context of Use” in eCTD v4.0

eCTD v4.0 Release

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Embracing eCTD v4.0

August 1, 2024 – As we conclude our 12-week blog series exploring the transition from eCTD 3.2.2 to eCTD 4.0, it’s essential to reflect on the key considerations and potential benefits for sponsors. While the journey may seem daunting, embracing eCTD 4.0 can streamline regulatory submissions, enhance document management and ultimately drive significant returns on investment.

Training and Staying Up-to-Date

Successful adoption of eCTD 4.0 requires comprehensive training and education for internal teams. Sponsors should invest in training programs that cover relevant terminology, concepts and the latest ICH and regional guidelines. Keeping teams updated on evolving regulatory requirements and best practices is crucial for maintaining compliance and maximizing the benefits of eCTD 4.0.

Navigating the Transition Period

While eCTD 4.0 is gaining traction, support for eCTD 3.2.2 submissions must continue until the new standard becomes universally mandatory. This transition period may extend until 2029 for some regions, leading to an overlap in submission formats. Sponsors must be prepared to manage and maintain both eCTD 3.2.2 and eCTD 4.0 submissions during this period, ensuring compliance and consistency across different regulatory bodies.

The Benefits of eCTD 4.0

Despite the challenges, eCTD 4.0 offers numerous benefits that can drive significant ROI for sponsors:

1. Unified Format: eCTD 4.0 provides a standardized format for submissions across multiple agencies, regions and centers, reducing the need for structural changes and facilitating global compliance.
2. Enhanced Metadata and Keyword Definitions: Improved metadata management and the use of controlled vocabularies enhance document organization, searchability and traceability.
3. Improved Display Names and Submission Structure: eCTD 4.0 introduces more intuitive display names and a streamlined submission structure, improving navigation and readability.
4. Advanced Lifecycle Management: The introduction of unique document IDs and standardized lifecycle operations enables efficient document reuse, versioning, and lifecycle management across submissions.
5. Regulatory Communication: eCTD 4.0 supports optional two-way communication with regulatory bodies, facilitating collaboration and streamlining the submission process.
6. Regional Adaptation: While eCTD 4.0 provides a unified format, sponsors must adapt to regional differences and requirements to maximize the potential benefits and ensure compliance.

Embracing eCTD 4.0 is a journey that requires careful planning, investment in appropriate tools and training and a commitment to continuous improvement. By addressing the challenges head-on and leveraging the benefits of the new standard, sponsors can streamline regulatory submissions, enhance document management and ultimately drive significant returns on investment.

Author: Adrian Alderfer, LexisNexis Reed Tech

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Things to Consider While Navigating the Transition from eCTD 3.2.2 to eCTD 4.0

July 25, 2024 – As the life sciences industry embraces the latest electronic submission standards, the transition from eCTD 3.2.2 to eCTD 4.0 presents a set of challenges that require careful consideration. However, this transition also brings a host of benefits that promise to revolutionize the regulatory submission process. Here are the key aspects to keep in mind during this pivotal shift and highlight the advantages of adopting eCTD 4.0.

Challenges to Address:

1. Complexity of eCTD 4.0 XML: The eCTD 4.0 XML format is intricate, and manual adjustments can be a daunting task. Proper tools are necessary for lifecycle management between eCTD v3.2.2 and v4.0, ensuring seamless integration and compliance.

2. Viewing Submissions: One notable challenge is the absence of a stylesheet to view eCTD 4.0 submissions’ Table of Contents (ToC) and content in a browser. This limitation underscores the importance of robust submission management tools to navigate and review eCTD 4.0 submissions effectively.

3. PDF Preparation: Ensuring all PDFs are prepared for submission with the latest compression standards is crucial. This step not only optimizes file sizes but also ensures compatibility with regulatory requirements.

4. Metadata Management: Consistent use of metadata (user-defined vocabulary) is essential in both eCTD 3.2 and 4.0 submissions. Maintaining a standardized approach to metadata will facilitate smoother transitions and enhance data integrity.

5. Training and Education: Invest in training internal teams on relevant terminology and concepts, and keep them updated on the latest ICH and regional guidelines. A well-informed workforce will be better equipped to navigate the complexities of eCTD 4.0 and ensure compliance.

6. Parallel Submissions: Support for eCTD 3.2 must continue until eCTD 4.0 is universally mandatory, which may be until 2028 for some regions. This overlap in submissions necessitates a robust strategy to manage both formats concurrently, ensuring seamless operations and regulatory compliance.

Benefits of eCTD 4.0:

1. Unified Format: eCTD 4.0 offers a unified format for multiple agencies, regions and centers, streamlining the regulatory submission process and reducing the need for structural changes in submissions.

2. Enhanced Metadata and Keyword Definitions: eCTD 4.0 introduces improved metadata and keyword definitions, enhancing the organization and searchability of submission content.

3. Improved Display Names and Submission Structure: The new standard improves display names and submission structure, making it easier to navigate and understand the content.

4. Advanced Lifecycle Management: eCTD 4.0 introduces advanced lifecycle management capabilities, facilitating document reuse and ensuring consistency across submissions.

5. Optional Two-Way Communication: The standard supports optional two-way communication with regulatory bodies, enabling more efficient and collaborative interactions.

6. Regional Adaptation: While eCTD 4.0 offers a unified format, adaptation to regional differences is crucial for maximizing its potential and ensuring compliance with local regulations.

As you embark on this transition, it’s essential to partner with experienced solution providers who can guide you through the process, offering tailored tools and expertise to streamline your eCTD 4.0 adoption journey. By addressing the challenges and leveraging the benefits of eCTD 4.0, you’ll be well-positioned to navigate the complexities of the new standard and maintain a competitive edge in the ever-evolving regulatory landscape.

Author: Adrian Alderfer, LexisNexis Reed Tech

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Document Titles: Precision in Content Identification

July 18, 2024 –  eCTD v4.0 includes new requirements for document titles and how they can enhance content identification and navigation for reviewers.

In previous versions of eCTD, document titles were often inconsistent or lacked sufficient detail, making it challenging for reviewers to quickly identify the content and purpose of each document. This could lead to confusion, delays, and potential errors during the review process.

eCTD v4.0 addresses this issue by introducing specific guidelines and requirements for document titles. These guidelines aim to ensure that document titles are clear, concise, and accurately reflect the content of the document.

Here are some key changes and requirements for document titles in eCTD v4.0:

1. Standardized Naming Conventions: eCTD v4.0 provides a standardized naming convention for document titles, ensuring consistency across submissions and organizations.

2. Descriptive Titles: Document titles should be descriptive and provide enough information to clearly identify the content and purpose of the document. This includes specifying the document type, study or product name, and any other relevant details.

3. Unique Identifiers: In cases where multiple documents of the same type are included, unique identifiers should be used to differentiate them (e.g., “Study Report 1,” “Study Report 2,” etc.).

4. Version Control: Document titles should include version information, such as the date or version number, to ensure that reviewers can easily identify the most up-to-date version.

The benefits of implementing precise and descriptive document titles in your eCTD v4.0 submissions include:

1. Improved Navigation: Reviewers can quickly locate and identify the specific documents they need, reducing the time spent searching through the submission.

2. Enhanced Clarity: Clear and informative titles provide better context and understanding of the document’s content, minimizing the need for additional clarification or requests for information.

3. Consistency: By following standardized naming conventions, you can ensure consistency across your submissions, making it easier for reviewers to navigate and compare information.

The Return on Investment (ROI) for implementing precise document titles in your eCTD v4.0 submissions is significant. By improving navigation and clarity, you can streamline the review process, potentially leading to faster approval times and reduced costs associated with rework or clarification requests. Additionally, by providing a better user experience for reviewers, you can enhance the overall quality and efficiency of the regulatory review process.

As you prepare for the transition to eCTD v4.0, consider how you can implement clear, descriptive, and standardized document titles that accurately reflect the content and purpose of each document. This simple change can have a substantial impact on the clarity and efficiency of your regulatory submissions.

Author: Adrian Alderfer, LexisNexis Reed Tech

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Descriptive Submission Unit Titles Guide Reviewers

July 11, 2024 – eCTD v4.0 includes a new requirement for more descriptive Submission Unit titles, enhancing clarity and navigation for reviewers.

In previous versions of eCTD, the titles for Submission Units (sequences) were often brief and generic, providing little context about the content or purpose of the submission. This could make it challenging for reviewers to quickly identify the relevant information they need.

eCTD v4.0 addresses this issue by mandating the use of more descriptive and informative titles for Submission Units. These titles should clearly convey the purpose, content and context of the submission, making it easier for reviewers to navigate and understand the submission structure. For example, instead of a generic title like “Sequence 0001,” you might use a more descriptive title such as “Initial Marketing Authorization Application for Product X – Clinical Study Reports.” This immediately provides reviewers with valuable context about the submission’s content and purpose.

The benefits of using descriptive Submission Unit titles include:

1.  Improved Navigation: Reviewers can quickly identify and locate the relevant information they need, reducing the time spent searching through the submission.

2.  Enhanced Clarity: Clear and informative titles provide better context and understanding of the submission’s content, minimizing the need for additional clarification or requests for information.

3.  Consistency: By following a standardized approach to titling, you can ensure consistency across your submissions, making it easier for reviewers to navigate and compare information.

The ROI for implementing descriptive Submission Unit titles in your eCTD v4.0 submissions is significant. By improving navigation and clarity, you can streamline the review process, potentially leading to faster approval times and reduced costs associated with rework or clarification requests. Additionally, by providing a better user experience for reviewers, you can enhance the overall quality and efficiency of the regulatory review process.

As you prepare for the transition to eCTD v4.0, consider how you can implement clear and informative Submission Unit titles that accurately reflect the content and purpose of your submissions. This simple change can have a substantial impact on the clarity and efficiency of your regulatory submissions.

Author: Adrian Alderfer, LexisNexis Reed Tech

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Application References: Cross-Referencing for Clarity

July 3, 2024 – The new Application References feature in eCTD v4.0 can bring more clarity and efficiency to your regulatory submissions. Application References, also known as Cross-Referencing, is a powerful tool that allows you to link related information across different sections of your eCTD submission. While cross-referencing was possible in previous versions of eCTD, the v4.0 standard introduces significant enhancements to this functionality.

In eCTD v3.2.2 and earlier versions, cross-referencing was limited to hyperlinks within the same document or between documents within the same section. This approach had limitations, as it did not provide a comprehensive way to link information across different sections of the submission. eCTD v4.0 addresses this limitation by introducing a dedicated Application References section (Module 1.4.4) where you can create and manage cross-references across the entire submission. This centralized approach ensures that all cross-references are easily accessible and maintainable.

Here’s how it works: Instead of duplicating the same information in multiple sections, you can create a reference to the original location in Module 1.4.4. This not only reduces redundancy but also ensures consistency across the submission, minimizing the risk of contradictory or outdated information. For example, if you have a particular study report that is relevant to both the Clinical and Non-Clinical sections, you can include the report in one section and create a reference to it in the other. This way, reviewers can access the same information without having to search through multiple locations.

The benefits of Application References extend beyond just cross-referencing:

1. Improved Clarity: By providing clear links between related information, reviewers can better understand the context and relationships within your submission.
2. Reduced Redundancy: Eliminating the need to duplicate data across sections can significantly reduce the overall size of your submission, making it more manageable and efficient.
3. Consistency: With a single source of truth for each piece of information, you can ensure that all references point to the most up-to-date and accurate data, minimizing the risk of inconsistencies.
4. Streamlined Updates: If you need to update a particular piece of information, you only need to modify it in one location and all references will automatically point to the updated content.

The Return on Investment (ROI) for implementing Application References in your eCTD v4.0 submissions is substantial. By improving clarity, reducing redundancy and ensuring consistency, you can streamline the review process, potentially leading to faster approval times and reduced costs associated with rework or clarification requests.

As you prepare for the transition to eCTD v4.0, consider how Application References can enhance the quality and efficiency of your regulatory submissions.

Author: Adrian Alderfer, LexisNexis Reed Tech

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Ensuring Proper Submission Classification

June 27, 2024 – eCTD v4.0 aims to improve in providing clear guidance around submission tracking information, specifically the application types allowed for different submission types. This clarification ensures submissions are properly classified upfront, avoiding potential issues during processing and review.

The submission tracking information guidelines in v4.0 outline the acceptable application types (e.g. NDA, ANDA, BLA) that can be used when sending particular submission types like original applications, amendments or supplements. As stated in the eCTD v4.0 guidance, “Submission tracking information provides a mechanism to identify the type of submission and application to which it belongs” (ICH, 2020).

Facilitating Efficient Review Processes

By aligning the application and submission types correctly per the new guidelines, regulatory authorities can efficiently triage, route and review the submissions without delays from improper categorization. Accurate submission tracking information streamlines the intake and processing workflow. For example, an original NDA submission would be clearly distinguished from an amendment to an existing ANDA application based on the specified codes. This allows health authorities to quickly identify the application context and route it to the appropriate review group.

The ROI Benefits for Sponsors

For sponsors, adhering to the submission tracking information guidelines provides several key ROI benefits:

1. Reduced Submission Queries/Rejects: Properly mapping application and submission types upfront minimizes the need for regulatory authorities to query improper classifications. This prevents submission rejection and rework, saving significant time and costs.
2. Faster Review Cycles: Correct submission categorization allows for optimized processing and routing to reviewers, reducing administrative delays. Submissions can proceed through the review workflow more efficiently.
3. Improved Compliance: Aligning with the v4.0 guidelines prevents submission deficiencies and ensures adherence to the latest standards, mitigating potential compliance risks.
4. Streamlined Regulatory Operations: Clear submission tracking information facilitates more structured regulatory processes and interactions with health authorities (Mullon, 2022).

Overall, the submission tracking information guidelines in eCTD v4.0 promote efficiency through accurate upfront classification. This facilitates smoother regulatory interactions and faster review cycles, translating into significant time and cost savings for sponsors’ regulatory operations.

References: ICH (2020) Electronic Common Technical Document (eCTD) v4.0; Mullon, C. (2022). Streamlining Regulatory Submissions with eCTD v4.0. Journal of Regulatory Affairs, 12(3), 28-35.

Author: Adrian Alderfer, LexisNexis Reed Tech

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Seamless Transition with Forward Compatibility

June 20, 2024 – As the eCTD specification evolves from version 3.2.2 to the new 4.0 version, forward compatibility is a critical consideration to enable a smooth transition for existing submissions. The eCTD v4.0 specification addresses this need by ensuring comprehensive forward compatibility that preserves the context of use and metadata integrity from prior eCTD versions.

During the migration process from eCTD 3.2.2 to v4.0, the forward compatibility functionality automatically maps and translates document context and metadata in an appropriate manner. This robust translation allows the transition to be simplified, minimizing any potential disruption or loss of data integrity. Existing eCTD 3.2.2 submissions can be efficiently migrated while maintaining all relevant document context, relationships and associations intact. The hierarchical structure, document groupings and rich metadata are carried over seamlessly into the new eCTD v4.0 format through the forward compatibility capabilities.

Streamlining the Upgrade Path

The forward compatibility support streamlines the upgrade path to eCTD v4.0 for sponsors with an established base of eCTD 3.2.2 submissions. There is no need for complex data transformations or rebuilding of the entire eCTD structure from scratch during the transition. As stated in the eCTD v4.0  guidance, the forward compatibility mechanisms “ensure the context of use and metadata persist through the transition, providing consistency in the presentation of the submission content” (ICH, 2020). This consistency ensures all historical submission data remains fully accessible and meaningful under the new v4.0 specifications.

Maintained Business Continuity

Lastly, and perhaps most crucially, forward compatibility prevents any disruption to sponsors’ existing eCTD operations and review experiences with regulators. Historical submissions remain fully accessible in their original contextualized state.

This continuity mitigates the risk of costly delays, rework or lost productivity during the transition period. Sponsors can continue established processes while upgrading to v4.0 incrementally. Overall, the forward compatibility mechanisms in eCTD v4.0 facilitate a low-risk, low-cost migration path for sponsors. By maximizing reuse of existing assets while preventing disruptions, it provides a clear ROI through reduced transition costs, accelerated adoption of v4.0 capabilities and maintained business continuity.

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

Author: Adrian Alderfer, LexisNexis Reed Tech

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Maximizing Efficiency Through Document Reuse in eCTD v4.0

June 13, 2024 – In the realm of regulatory submissions, eCTD v4.0 emerges as a pivotal advancement, offering enhanced support for document reuse across applications and submissions. This innovative feature significantly reduces the need for repetitive submissions of identical core documents, streamlining processes for both sponsors and regulators.

Previous Version vs. eCTD v4.0

In earlier versions of eCTD, such as eCTD v3.2.2, sponsors were required to include the same core documents repeatedly across multiple submissions, leading to increased workload and redundancy. Each new submission necessitated the re-inclusion of previously submitted documents, which not only consumed time but also increased the volume of data to be reviewed by regulators.

With eCTD v4.0, sponsors can now leverage previously submitted documents using unique identifiers rather than resubmitting the same documents with each new submission. For instance, a new marketing application can reference clinical study reports from prior submissions simply by specifying relevant identifiers. This means that reviewers can access all previously submitted information without the redundancy of large documents being included multiple times across different applications.

Real-Life Application and ROI

For sponsors, the document reuse functionality simplifies the submission process by eliminating redundant work. There’s no need to repackage and resubmit identical documents for different submissions or applications, which translates into substantial time and effort savings.

From a regulatory standpoint, document reuse enhances efficiency by allowing reviewers to quickly locate and access all relevant prior documents using unique identifiers, even across various applications from the same sponsor. According to the eCTD v4.0 guidance, this “provides an optimized review experience” by making all pertinent information readily accessible (ICH, 2020).

Moreover, document reuse reduces the overall submission size and data transfer requirements. By referencing identifiers instead of resubmitting entire documents, less redundant data is transmitted through regulatory gateways, making the process more efficient.

Streamlined for the Future

The support for document reuse in eCTD v4.0 maximizes efficiency by reducing duplication, repetitive efforts and data transfer needs. As the adoption of this new specification grows across the industry and regulatory bodies, all parties can expect significant time and cost savings. This capability streamlines lifecycle management and optimizes regulatory information management, paving the way for a more efficient future in regulatory submissions.

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

Author: Adrian Alderfer, LexisNexis Reed Tech

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Streamline Document Lifecycle Management with Improved Context Groups in eCTD v4.0

June 6, 2024 – Effective document lifecycle management is crucial for maintaining clarity and traceability in regulatory submissions. eCTD v4.0 introduces enhancements to streamline this process through improved context groups. This new approach allows for more comprehensive replacements that incorporate multiple related documents, providing better visibility into the evolution of submission materials.

In previous eCTD versions, document replacements were limited to swapping out individual files one-for-one. However, eCTD v4.0 context groups enable replacing a set of documents as a consolidated unit. For example, a new clinical study report could replace the previous report version along with supplementary documents like protocols, analysis files and raw data. This integrated replacement maintains a clear, consolidated history of changes and revisions.

The context group functionality provides several key benefits. For sponsors, it reduces effort by simplifying the replacement process across interrelated documents that should be updated together. There is no longer a need to manually replace each individual file. Instead, the complete context of revised materials can be updated in one seamless operation.

From a reviewer perspective, seeing the full context of revised documents helps track the evolution of the submission more easily and transparently. There is better traceability of what was changed, when and why. Reviewers can quickly understand how the submission has been updated over time without having to cross-reference various document versions manually.

According to the eCTD v4.0 guidance, this improved lifecycle management approach “ensures a comprehensive view of the current submission content and its history” (ICH, 2020). As a result, eCTD v4.0 context groups enhance lifecycle management, improve transparency into document updates and facilitate more efficient submission review.

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

 Author: Adrian Alderfer, LexisNexis Reed Tech

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Transition from Attributes and Values to Keywords

May 30, 2024 – One notable change in eCTD v4.0 is the replacement of the previous attribute and value system with a more robust keyword approach for document identification and organization. In prior eCTD versions, documents were categorized using a defined set of attributes (e.g. document type, study details) and corresponding values. This rigid structure lacked flexibility.

The New Flexible Keyword Approach

Keywords in eCTD v4.0 allow for more descriptive and customized labeling of documents. Sponsors can apply relevant keywords to precisely indicate details like the document type, study information, product name and more. This enables a refined level of document identification compared to the limited attributes and values previously available.

Benefits for Clients

Greater Flexibility and Consistency: The keyword approach provides greater flexibility in how documents are organized and identified within an eCTD submission. It allows for more granular, context-specific labeling rather than broad attributes. This increased flexibility also promotes consistency, as keywords can be applied systematically across documents and submissions.

Enhanced Findability and Navigation: For reviewers, descriptive keywords enhance the findability and navigation of documents within the eCTD structure. They can quickly locate the specific materials they need by filtering on applicable keywords, rather than sifting through documents categorized with generic attributes and values.

Improved Context and Organization: Keywords help provide valuable context about the document content and where it fits within the overall submission. The eCTD v4.0 guidance recommends utilizing keywords judiciously to categorize documents in a clear and consistent manner. When applied systematically, keywords ensure documents are easily identifiable, accessible and well-organized for reviewers.

As clients transition to eCTD v4.0, taking full advantage of this flexible keyword approach will lead to improved organization, navigation and efficiency in regulatory submissions.

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

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

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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

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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 https://www.ich.org/page/ectd-v4-0

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