Introduction

The CTD was developed by the ICH (International Conference on Harmonisation) in order to provide a common format for the submission of information in support of the registration of pharmaceutical/biological products to regulatory agencies in the three ICH regions: US, EU & Japan (Observers include Canada, Switzerland and the World Health Organization (WHO)). The CTD describes a logical ordering and organization of information. It also provides a way of managing information at a document level.

The Common Technical Document is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Conformance with this guideline should ensure that these four modules are provided in a format acceptable to the regulatory authorities.

Module 1.

Administrative Information and Prescribing Information

This module contains information specific to the region to which the dossier is being submitted. The relevant regulatory authorities specify the content and format of this module.

Module 2.

Common Technical Document Summaries

Module 2 contains summaries and overviews of the 3 CTD technical sections: Quality, Safety and Efficacy. The organization of these summaries is described in separate guidance documents for each discipline (Quality, Safety and Efficacy).

Module 3.

Quality

Module 3 contains information pertinent to the Quality of the pharmaceutical (drug or biologic) substance and product. This consists of information concerning the Chemistry, Manufacturing and Controls of the drug/biologic substance and product.

Module 4.

Nonclinical Study Reports

Module 4 contains information on the nonclinical (pharmacological, pharmacokinetic and toxicological) evaluation of the drug/biologic substance and product. This information is typically provided in the form of study reports and publications.

Module 5.

Clinical Study Reports

Module 5 contains information on the clinical evaluation of the drug/biologic product. This module typically includes Clinical Study Reports describing each conducted clinical study. Supportive publications are also provided here. In addition, in U.S. submissions, datasets and Case Report Forms (CRFs) are provided in Module 5.
The overall organization of the Common Technical Document is presented as follows:

Pyriamid Diagram

The eCTD (electronic Common Technical Document) is the delivery mechanism for the electronic submission of a CTD. The eCTD specifications include guidance’s around file size, file naming, file properties, etc.