eCTD

The electronic Common Technical Document (eCTD) is an international specification designed for the submission of regulatory information in the pharmaceutical industry.

It serves as an interface for the transfer of regulatory documents between pharmaceutical companies and regulatory authorities.

The eCTD format is based on the traditional Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) to streamline the submission process across different regions and agencies.

 

Advantages using eCTD

  • Standardization: It provides a standardized format for submissions, which simplifies the process for both the submitters and the regulatory authorities.
  • Efficiency: By using an XML backbone, the eCTD allows for cross-linking of documents and metadata, enhancing the organization and retrieval of information during the review process
  • Global Acceptance: Many regulatory agencies worldwide, including the FDA, require submissions in the eCTD format, making it essential for companies looking to market their products internationally.

Content

  • Module 1: Regional administrative information and prescribing information.
  • Module 2: Summaries of the quality, safety, and efficacy of the product.
  • Module 3: Quality information about the drug substance and drug product.
  • Module 4: Non-clinical study reports.
  • Module 5: Clinical study reports
Metadata: Each submission includes metadata that aids in the lifecycle management of the files, helping to define and describe the components of the submission

Document Types: The eCTD can include various document types such as clinical study reports, manufacturing information, and labeling, all formatted to meet regulatory requirements.

Why a eCTD graph version

Having an eCTD structure in graph format offers significant advantages, primarily through the standardization of document structure and components, which aligns with established document types and concepts, such as those compliant with the Identification of Medicinal Products (IDMP) ontology.

This structured approach facilitates the quick integration of new concepts and allows for seamless linking to relevant datasets, data products, and regulatory processes.

By representing the eCTD as a graph, stakeholders can easily navigate complex relationships between documents and data, enhancing the efficiency of regulatory submissions and reviews while ensuring that all components are interconnected and easily accessible.