Understanding the Common Technical Document (CTD)

The Common Technical Document (CTD) is a set of specifications for a dossier for the registration of medicines. The CTD was developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and adopted by the Therapeutic Goods Administration (TGA) in 2004.

Purpose

The CTD prescribes:

• the organisation of the dossier across 5 modules
• the order in which documents must appear so they are grouped logically and can be easily located.

Under the CTD format:

How to access a pdf document

• Each application is a collection of documents grouped into 5 modules as detailed below.
• The actual content of the dossier will vary according to the application category and application type.
• The format and content of Module 1 are described in this document.
• The format of Modules 2, 3, 4, and 5 is described in the relevant adopted CTD guidelines (see table below).
• The content of Modules 3, 4 and 5 (technical data requirements) will vary according to the application type and is described in the relevant Australian guidelines and adopted EU guidelines.
• See also: CPMP/ICH/5552/02 (pdf,162kb) ICH Topic M 4. Common Technical Document for the Registration of Pharmaceuticals for Human Use. Questions and Answers
  Provided for information: 7 October 2004

Terminology

Application

• Application refers to the regulatory activity required in respect of a product (a specific set of formulations, strengths and presentations) as requested by the applicant of the product.
• It is the specific set of information on the product submitted for review.
• Examples include:
  • an application for the registration of a new medicine
  • registration of a new indication.

Application category

• Application category is identified by a number, for example, category 1 and category 2 applications, and refers to the overall legislated time-frames for decisions about applications.

Application type

• Application type relates to the fees associated with an application and is identified by a letter, for example, A, B or C application types.
• Examples include:
  • new chemical entity
  • new indication or major variation.

Dossier

• A dossier contains and/or references the necessary data to demonstrate the quality, safety and efficacy of a prescription medicine.
• The supporting data consists of:
  • the dossier lodged in the first instance
  • any dossiers provided to the TGA previously that are referenced by the application
  • any other data to support the application that is lodged following initial lodgement of the application (for example, section 31 responses, further safety data).

Submission

• A submission is a collection of one or more applications that are grouped together for fee purposes, and is specific to a particular active ingredient and applicant.

Module 1: Administrative information and prescribing information for Australia

The format of Module 1 is unique to Australia and contains relevant administrative documentation.

• See: CTD Module 1

Module 2: Common technical document summaries

Module 2 summarises the information that will be provided in the quality (Module 3), nonclinical (Module 4) and clinical (Module 5) modules of the dossier.

There is no single document that explains the content of Module 2 for the registration of pharmaceuticals for human use. The documents for Modules 3, 4, and 5 include a section on the information that must be provided in Module 2.

• CTD for the registration of pharmaceuticals for human use - Quality overall summary of Module 2 and Module 3: CPMP/ICH/2887/99 Rev 1 Quality (pdf,292kb)
• CTD for the registration of pharmaceuticals for human use - Nonclinical overview and nonclinical summaries of Module 2 and organisation of Module 4: CPMP/ICH/2887/99 Rev 1 Safety (pdf,638kb)*
• CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: clinical study reports: CPMP/ICH/2887/99 Rev 1 Efficacy (pdf,474kb)

Module 3: Quality

Module 3 describes the format and organisation of the chemical, pharmaceutical and biological data relevant to the application. This module is an EU CTD document adopted in Australia.

How to access a pdf document

• CTD for the registration of pharmaceuticals for human use - Quality overall summary of Module 2 and Module 3: EU Module 3 - Quality (CPMP/ICH/2887/99 Rev 1 Quality) (pdf,292kb)

Module 4: Safety (nonclinical study reports)

Module 4 describes the format and organisation of the nonclinical (pharmaco-toxicological) data relevant to the application. This module is an EU CTD document adopted in Australia.

• CTD for the registration of pharmaceuticals for human use - Nonclinical overview and nonclinical summaries of Module 2 and organisation of Module 4: EU Module 4 - Nonclinical studies (CPMP/ICH/2887/99 Rev 1 Safety) (pdf,638kb)*

Module 5: Efficacy (clinical study reports)

Module 5 describes the format and organisation of the clinical data relevant to the application. This module is an EU CTD document adopted in Australia.

How to access a pdf document

• CTD for the registration of pharmaceuticals for human use - clinical overview and clinical summary of Module 2 and Module 5: EU Module 5 - Clinical Studies (CPMP/ICH/2887/99 Rev 1 Efficacy) (pdf,474kb)

Dossier documents matrix

The following tables provide a summary of CTD document requirements for each application type.

• Dossier documents matrix: Module 1
• Dossier documents matrix: Modules 2-5