Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Composition of the CTD.
| Content | |
|---|---|
| Module 1 | Administrative information (not formally part of the CTD). |
| Module 2 | Quality overall summary; nonclinical overview; nonclinical summary; clinical overview; clinical summary. |
| Module 3 | Chemical, pharmaceutical, and biological information for medicinal products containing chemical and/or biological active substances (quality). |
| Module 4 | Non-clinical studies report (safety). |
| Module 5 | Clinical studies report (safety and efficacy). |
