CTD Organization

In the course of applying for approval of a new drug, the quality, non-clinical, and clinical overview and summary sections of Module 2 (CTD Overviews and Summaries) are prepared based on the study results that are presented in Modules 3, 4, and 5. This information is ultimately compiled in Module 1.1 “Submission Table of Contents,” reflected in the package insert information, and the application is submitted. CTD is a compilation of various studies and clinical trials, and can be said to be the culmination of efforts and missions for numerous studies and clinical trials that have been conducted for a long time.