In the realm of regulatory submissions, ensuring efficient document management, accessibility, and compliance is paramount. One critical tool that aids in this process is an Electronic Common Technical Document (eCTD) viewer. An eCTD viewer allows users to navigate through eCTD submissions, view individual documents, and access related metadata, providing a comprehensive solution for regulatory document management. In this article, we will delve into the features and benefits of eCTD viewers, legal obligations surrounding their use, the need for organizations to have their own viewer, and the factors to consider when selecting a suitable eCTD viewer solution.
Basic eCTD Viewer Features
eCTD viewers come equipped with several features that enhance the accessibility and usability of eCTD submissions. Some of the common features include:
Document Navigation: Users can easily browse through the various sections and subsections of the eCTD submission, including the module structure and individual documents.
Document Viewing: The viewer allows users to view the content of each individual document within the eCTD submission. It may offer options for zooming, text searching, and text highlighting, enabling efficient document analysis.
Metadata and Lifecycle Tracking: eCTD viewers display essential metadata associated with each document, such as document type, version, submission date, and author. They may also indicate the status of each document within the submission lifecycle, such as "new," "replace," or "delete."
Hyperlinking and Cross-Referencing: eCTD viewers typically support hyperlinks within the submission, facilitating easy navigation between related documents or sections. This feature allows users to access relevant information quickly.
Do you NEED an eCTD Viewer?
Organizations involved in regulatory submissions often rely on Contract Research Organizations (CROs) or regulatory operations vendors for the creation and submission of their eCTD sequences. While the CRO or vendor usually provides a viewer for Quality Assurance/Quality Control (QA/QC) purposes before sending the submission to the agency, it is crucial for the sponsor to maintain a copy of the eCTD for compliance and inspection purposes. Legal obligations set by agencies, such as the US FDA, require sponsors to retain electronic documentation sent to the agency during clinical trials or marketing applications. By having their own eCTD viewer, sponsors can ensure compliance with regulatory guidelines and maintain a comprehensive, secure, and orderly record of their regulatory sequences.
Legal Obligations: Agency Requirements
Post-submission to regulatory agencies, sponsors must retain a copy of the eCTD in-house, as mandated by regulatory guidelines such as the Code of Federal Regulations Title 21 Part 31 and CFR Code 21 Pt 11 for the US FDA. Agency inspectors may request to review electronic records during inspections, making it essential to maintain compliant electronic records within a secure, read-only environment. Similarly, agencies from other regions, such as the UK, EU, and Health Canada, may inspect records related to clinical trial applications or market authorizations. By providing secure, limited access to the submission, organizations can streamline the inspection process and ensure regulatory compliance.
Legal Obligations: Mergers, Acquisitions, and Partnerships
Many companies partner or merge with other pharma and biotech organizations. For example, to out-license a product. Organizations involved in mergers, acquisitions, or partnerships must conduct due diligence, which includes a review of past regulatory activities. Understanding the submission history of drugs or biologics is crucial in providing critical material information. During due diligence, it is essential to provide a secure, read-only format of the eCTD submission for review. This includes intellectual property lists, regulatory status of products, filed/approved marketing applications, drug master files, and correspondence with governing agencies. Having an eCTD viewer allows organizations to control access, maintain documentation integrity, and provide a comprehensive view of their regulatory activities during the due diligence process.
As related to eCTDs or submission the following information needs to be provided in a secure read-only format for review during the proceedings:
- List of all intellectual property including products currently being marketed and under development.
- List of products under development and their regulatory statuses
- List of filed/approved marketing applications in the U.S. or abroad.
- List of drug master files (DMFs) filed by the company.
- Catalogs of the following: DMF (drug master files) deficiency letters, DMF annual update reports, companies authorized to reference DMFs, and FDA correspondences regarding the DMF
- Records of Investigational New Drug (IND) applications, including IND numbers, deficiency letters from the FDA, and other correspondence regarding acceptances or denials of approval of IND applications.
- List of statuses of foreign and domestic marketing applications, including NDAs, ANDAs, PLAs, and BLAs.
- Compilations of correspondence with governing agencies related to marketing applications, records of compliance in filing the applications, records of compliance with the Prescription Drug User Fee Act, records of compliance with reporting requirements for marketing applications in the U.S. and abroad, and records of compliance with any post market or Phase IV study obligations
You want to ensure that representatives performing the diligence review ONLY the correct submission for the correct drug. Having the power to limit access to one product within your viewing tool will ease the process and maintain control over the documentation. Audit trails will capture who accessed which document at any given point as well.
What are the benefits of an eCTD Viewer?
Benefits: Agency Questions during a Review
During the review process for clinical trials or marketing applications, regulatory agencies may request additional information or clarification. Efficiently locating the relevant content within the submission is crucial for timely responses. An in-house eCTD viewer enables users to quickly find the exact document in question, as well as any linked or connected content. For example, if a document references a specific section of a protocol, both documents may require changes. Furthermore, if there are multiple sequences, the viewer enables users to trace the history of a document throughout its lifecycle, ensuring accurate and contextually relevant responses to agency requests. Viewing the submission as the agency does provides the fastest and most accurate way to respond to requests for information.
Benefits: Preparing for the Future
As regulatory agencies transition to accepting eCTD version 4.0, requirements for viewing submissions will change. The current practice of opening the index.xml file in a browser with a style sheet will no longer be applicable. eCTD version 4.0 does not utilize a hierarchical structure or provide a style sheet for human readability. Instead, software will be required to "render" the XML into a human-readable format. The XML context and keywords will provide essential information such as module, section, and study ID. Furthermore, sponsors will have control over the ordering of documents within the submission. An eCTD viewer becomes a critical business tool for managing regulatory submissions, especially as agencies are already accepting pilot applications in the version 4.0 format.
Factors to Consider when Selecting an eCTD Viewer Solution
When choosing an eCTD viewer solution, organizations should carefully evaluate their requirements and consider the following factors:
Integration with Existing Systems: Assess whether the viewer can connect or integrate with an Electronic Document Management System (EDMS) or publishing system, ensuring seamless workflow integration.
Access and User Permissions: Determine who within your organization will require access to the viewer and ensure that user permissions can be properly configured to limit access to specific content.
Types of Views Supported: Consider the types of views supported by the viewer, such as cumulative, sequence, module, and search views, to ensure compatibility with your organization's needs.
User Community Support: Evaluate whether the viewer supports the operating systems used by your user community and whether it is user-friendly. Additionally, consider whether the solution is offered as a cloud-based solution, providing flexibility and accessibility.
Compliance and Validation: Verify that the viewer is compliant with electronic records regulations set by the relevant regulatory agencies in your region. Additionally, ensure that the solution provides an audit trail and enables control over user permissions.
Implementing an eCTD viewer empowers organizations to enhance transparency, access, and control over their regulatory document management processes. By providing easy navigation, metadata tracking, and comprehensive document viewing capabilities, eCTD viewers streamline QA/QC processes, meet compliance requirements, facilitate legal obligations, and prepare for future regulatory changes. When combined with an EDMS, an eCTD viewer becomes an indispensable tool for regulatory and executive teams, enabling them to efficiently manage submissions, respond to agency requests, and ensure successful compliance throughout the regulatory journey.