eCTD Dossier (Electronic Common Technical Document 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:
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:
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
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