Common Technical Document

Common Technical Document (CTD)

Common Technical Document (CTD) /ˈkɒmən ˈtɛknɪkəl ˈdɒkjʊmənt/ is a set of specification for application dossier for the registration of Medicines and drugs globally. It has been developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Etymology

The term "Common Technical Document (CTD)" is derived from its purpose in the pharmaceutical field. It is a "common" document as it is used globally, "technical" because it contains detailed information about the drug, and "document" as it is a formal written record.

Structure

The CTD is divided into five modules:

Administrative and prescribing information
Overview of module 2 to 5 and Quality Overall Summary (QOS)
Quality
Nonclinical Study Reports
Clinical Study Reports

Each module has its specific contents and is prepared in a manner that allows it to be reviewed independently.

Related Terms

Module 1: Contains information specific to each region; for example, application forms or prescribing information.
Module 2: Contains summaries of data and information provided in Module 3 to 5.
Module 3: Contains information about the quality of the drug.
Module 4: Contains nonclinical study reports.
Module 5: Contains clinical study reports.

Usage

The CTD is used in the process of applying for a new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the regulatory authorities such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

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Common Technical Document