eCTD

The electronic Common Technical Document (eCTD) is an documentation standard for the pharmaceutical industry to transfer of regulatory information. The structure and terms are based on the Common Technical Document (CTD) format.

All Sites:

Administrative Information and Prescribing Information
eCTD Module 1

Common Technical Document Summaries
eCTD Module 2

Quality
eCTD Module 3

Nonclinical Study Reports
eCTD Module 4

Clinical Study Reports
eCTD Module 5