Pharmaceutical Point of View
The eCTD has five modules:
- Administrative Information and Prescribing Information
- Common Technical Document Summaries
- Quality
- Nonclinical Study Reports
- 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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