Electronic Common Technical Document - Pharmaceutical Point of View

Pharmaceutical Point of View

The eCTD has five modules:

  1. Administrative Information and Prescribing Information
  2. Common Technical Document Summaries
  3. Quality
  4. Nonclinical Study Reports
  5. Clinical Study Reports

A full table of contents could be quite large.

There are two categories of modules:

  • Regional module: 1 (different for each region; i.e., country)
  • Common modules: 2-5 (common to all the regions)

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

Read more about this topic:  Electronic Common Technical Document

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