What is it about Electronic common technical document?

Posted by Aaryan Smith on May 11th, 2021

The electronic common technical document (eCTD) is an interface and an international specification for all the pharmaceutical industries and IT industries for the transfer of regulatory information for governing all of them. The specification here is based on the Common Technical Document (CTD) format, and the International Council developed it for Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). eCTD regulation submission's structure is vastly defined by the primary standard created by the ICH, the Electronic Common Technical Document Specification. However, additional specifications can be applied in national and continental contexts.

The eCTD regulation generally has five modules from a pharmaceutical point of view. They are

  • The administrative information and prescribing information for a company.
  • The common technical document summaries
  • The quality of the product
  • All nonclinical study reports
  • The clinical study reports
  • A full table of contents which are quite large.

There are two categories of modules:

  • Regional module: 1 this is generally different for each region or country.
  • Common modules: 2–5 they are all common to all the regions
  • The CTD defines the content only for all the common modules. The contents of the regional Module 1 are generally defined by each one of the ICH regions.

Governing specifications

eCTD submission's structure is primarily distinguished by the primary standard created by the ICH, i.e., the Electronic Common Technical Document Specification. However, many additional rules can also be applied in the national and continental contexts in different countries. In a context, the Food and Drug Administration (FDA) layer also gives additional specifications onto the things required for eCTD submissions, which generally includes PDF, transmission, file format, and supportive file specifications.

e-CTD regulation components for IT point of view

The eCTD is a message of specifications commonly known as the transfer of files and metadata from a submitter to the receiver of all the information.

The primary technical components required here are:

  • A high-level folder structure required for the submission of data
  • An XML "backbone" file provides metadata about all the content files and the lifecycle instructions for the receiving system.
  • An optional lower level folder structure which is generally a recommended folder name that are provided in Appendix 4 of the eCTD specification
  • All the associated document type definitions (DTDs) and stylesheets of the IT product
  • Each submission message always constitutes one "sequence." A cumulative eCTD always comprises one or more than one way of submission. While a single sequence may be viewed with a web browser and the ICH stylesheet provided, generally, a cumulative eCTD requires many specialized eCTD viewers.

Source: https://www.apsense.com/article/what-is-it-about-electronic-common-technical-document.html

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Aaryan Smith

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Aaryan Smith
Joined: January 29th, 2018
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