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.
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.
Overview
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:
- 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
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.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
- 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 | Content |
|---|---|
| 2.1 | Common technical document table of contents (Modules 2–5) |
| 2.2 | CTD introduction |
| 2.3 | Quality overall summary |
| 2.4 | Nonclinical overview |
| 2.5 | Clinical overview |
| 2.6 | Nonclinical written and tabulated summaries
|
| 2.7 | Clinical summary
Literature references Synopses of individual studies |
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.
| Module | Content |
|---|---|
| 3.1 | Module 3 table of contents |
| 3.2 | Body of data |
| 3.3 | Literature references |
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.
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.
| Module | Content |
|---|---|
| 4.1 | Module 4 table of contents |
| 4.2 | Study reports |
| 4.3 | Literature references |
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.
| Module | Content |
|---|---|
| 5.1 | Module 5 table of contents |
| 5.2 | Tabular listing of all clinical studies |
| 5.3 | Clinical study reports |
| 5.4 | Literature references |
Dossier documents matrix
The following tables provide a summary of CTD document requirements for each application type.