eCTD Dossier (Electronic Common Technical Document Dossier)

eCTD Dossier

The 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 US FDA and Europe EMEA announced that the eCTD is the preferred format for electronic submission (eSubmisson) of Drug Dossiers. The drug manufacturer has to submit the drug dossier in eCTD format.

The eCTD Dossier contains following modules:

eCTD_Electronic_Common_Document_Structure
Fig: eCTD Dossier Format
  • 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 Dossier Format

The eCTD is a message specification for the transfer of Drug Dossier information from a submitter to a receiver in electronic form. The primary technical components are as follows:

Electronic Common Document (eCTD) Sample Folder
Fig: eCTD Dossier 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 eCTD Dossier submission message constitutes one "sequence". A cumulative eCTD Dossier consists of one or more sequences.



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Tags: eCTD dossier submissions , CTD & eCTD Submissions , Regulatory compliant dossier Submissions , US FDA Submissions , EMEA Submissions , ANDA submissions , Regional (Canada, EU, US) support , Electronic Common Technical Documenr (eCTD), CTD Format eCTD Dossier Format & Structure eCTD Dossier Preparation & Submission Service

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