The document describes how to organize applications based on the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines on the CTD. The CTD is currently only applicable to human, not veterinary, medicines.

This guideline describes the following points;

  • Module 1 – Administrative information and prescribing information
  • Module 2 – Summary of the dossier
  • Module 3 – Quality
  • Module 4 – Non-clinical study reports
  • Module 5 – Clinical study reports
  • European Union guidelines on quality, safety, and efficacy
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This document lists and briefly describes the updates and fixed issues included in the release of
the Jordan Module 1 eCTD Specification version 1.1 compared to version. 1.0.2.

This article describes the following points;

  1. Editorial Changes
  2. Changes in Envelope Data
  3. Changes in Submission Type
  4. Change of Sections Titles
  5. Change in Directories


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Prior to scheduling a submission appointment, all applicants should go through the
Frequently Asked Questions mentioned below:

  • What is an Application number?
  • When is the Application Number issued?
  • Where is the Application number reflected in an eCTD submission?
  • Where is “number” reflected in eCTD submission?
  • What is the UUID? etc.
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