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Common technical document (CTD)

28 April 2011

Submission dossiers for applications to register a prescription medicine on the Australian Register of Therapeutic Goods must be lodged in the common technical document (CTD) format.

Where European Union (EU) guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation.

What is the CTD?

The CTD is an internationally agreed set of specifications for a submission dossier. The structure of the CTD is described in detail in CPMP/ICH/2887/99. General Questions and Answers about the CTD have been published by the EMA.

How to access a pdf document

The specifications for the CTD were finalised in November 2000 and have been in use at the TGA since November 2004. The international adoption of the CTD enables the same dossier (except for Module 1) to be submitted to all regulatory agencies. With all submitted dossiers being structured in the same way (as specified in the CTD), it is easier for regulators to identify the types of information included in each dossier.

The CTD is divided into five modules.

Module 1

A regional specific module containing administrative information, and is unique to each regulatory authority. Several versions of Module 1 are currently in use in Australia.

Module 2

Contains overviews, written summaries and tabulated summaries of the data contained in Modules 3, 4 and 5

How to access a pdf document

*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 3

Contains quality data relating to the drug substance and drug product

Module 4

Contains nonclinical data

Module 5

Contains clinical data

Please note that the EU Modules 3 - 5 have been adopted by the TGA without their annexes (which are lists of Guidelines currently 'in force' in Europe).

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The Australian Module 1

Sponsors should refer to the TGA Module 1 for Australian-specific requirements and details regarding the physical aspects of a submission dossier, such as pagination. Several versions of TGA Module 1 are currently in use. This is because the submission process to the TGA is currently being streamlined (as part of the Prescription Medicines Business Process Reform project). The process changes have necessitated changes to the Module 1 requirements.

The different versions of Module 1, and where each is applicable, are described below.

Transitional CTD Module 1 – January 2011 version

The January 2011 version of Module 1 applies to submissions lodged with the TGA from 1 March 2011 onwards:

How to access a pdf or Word document

*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.

This version builds upon the significant changes introduced in the September 2010 version to provide further clarification of requirements. Like the September 2010 version, the January 2011 version is being released as a transitional document. The TGA therefore welcomes all feedback to support further improvements; comments should be emailed to the BPR Project team.

Transitional CTD Module 1 – September 2010 version

The September 2010 version of Module 1 is the reference document for submissions lodged with the TGA from 1 November 2010 to 28 February 2011, inclusive.

This version includes the requirements for submissions lodged in accordance with the streamlined submission process and was developed to assist sponsors with preparing high quality submission dossiers - a critical factor in the success of the streamlined submission process.

CTD Module 1 – November 2008 version

This version of the TGA CTD Module 1 was superseded on 1 November 2010 and must not be used for the preparation of prescription medicine submission dossiers. The November 2008 version of CTD Module 1 has been retained for the short term, to allow sponsors to access:

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