CTDの構成

新薬承認申請過程ではモジュール3、4、5の試験結果に基づき、モジュール2(CTDの概要)、すなわち、品質/非臨床/臨床の概括評価(Overview)及び概要(Summary)が作成されます。それらの情報は、最終的にモジュール1.1「申請資料の目次」としてまとめられ、添付文書情報に反映されて、申請に至ります。CTDは各種試験と臨床試験の総まとめであり、長い間実施してきた数々の試験と臨床試験に対する努力と使命感の結晶とも言えます。

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.


CTD
Module