Electronic Common Technical Document (eCTD)

Electronic Common Technical Document (eCTD)

The Electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to transfer regulatory information with various regulatory agencies. The content is based on the Common Technical Document (CTD) format.

It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). The U.S. FDA and EU EME announced that the eCTD is the preferred format for electronic submissions. The eCTD has five modules:

Fig: Electronic Common Techical Document
  • Module 1 - Administrative Information and Prescribing Information
  • Module 2 - Common Technical Document Summaries
  • Module 3 - Quality
  • Module 4 - Nonclinical Study Reports
  • Module 5 - Clinical Study Reports

The CTD defines the content only of the common modules (M2 to M5). However, the contents of the Module 1 (Regional Module) are defined by each of the ICH regions (USA, Europe and Japan).

eCTD Format/Structure

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver in electronic form. The primary technical components are:

Electronic Common Document (eCTD) Sample Folder
Fig: Electronic CTD Folder Structure
  • A high level folder structure (required)
  • An optional lower level folder structure
  • Recommended files name
  • Associated Document Type Definitions (DTDs) and stylesheets
Each submission message constitutes one "sequence". A cumulative eCTD consists of one or more sequences.

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