Common technical document (CTD)
The TGA only accepts applications to register prescription medicines in the Common Technical Document (CTD) format. The final date for submissions in the 'old European Union (EU) format was 30 June 2004.
Sponsors should refer to the TGA Module 1 for Australian specific requirements and details regarding pagination etc.
NB. Please note that the EU Modules 3 - 5 have been adopted without their annexes (which are lists of Guidelines currently 'in force' in Europe).
For a list of EU/ICH guidelines adopted in Australia, please refer to: European Union guidelines adopted in Australia <http://www.tga.gov.au/docs/html/euguidad.htm>.
TGA Module 1
TGA Module 1 - Australian specific requirements (pdf,178kb)
Note: TGA Module 1 is currently being updated to ensure consistency with the new streamlined submission processes that will commence on 1 November 2010 and to improve transparency around submission dossier requirements. The new version of the TGA Module 1 is due for release in August 2010.
To ensure that you are notified when the new version is released, you should subscribe to TGA's email updates.
EU Module 2 - CTD summaries
*Large file warning: Attempting to open large pdf 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.
- Quality - CPMP/ICH/2887/99 Rev 1 Quality (pdf,292kb)
- Safety - CPMP/ICH/2887/99 Rev 1 Safety (pdf,638kb)
- Clinical Studies - CPMP/ICH/2887/99 Rev 1 Efficacy (pdf,474kb)
EU Module 3 - Quality
EU Module 4 - Safety (non-clinical study reports)
EU Module 5 - Clinical study reports
Forms
- Application form <http://www.tga.gov.au/docs/html/pmrvform.htm>
More information
For queries regarding the preparation of dossiers in the CTD format, sponsors should contact the Application Entry Team (AET) of the TGA on 02 6232 8131.
eCTD project
The TGA has initiated a project that will culminate with the data dossiers for all prescription medicine applications being received in electronic CTD (eCTD) format. The eCTD has been specified by a Working Group of the International Conference on Harmonisation to facilitate the electronic submission of Common Technical Document (CTD) dossiers from applicant to regulator and the functionality in creating, viewing and reviewing those dossiers. Refer http://estri.ich.org/index.html <http://estri.ich.org/index.html>.
The TGA project will:
- develop a specification for the Australian Module 1 (Region Specific information) of the eCTD (pdf,251kb),
- identify the TGA requirements for viewing/reviewing software and initiate procurement of that software. The Request for Tender is available from the AusTender website,
- identify internal technical requisites and integration with other business systems,
- identify the changes to our business rules necessary for processing eCTDs, and
- produce Guidance for Industry.
It is expected that the media for receiving eCTDs initially will be CDs or DVDs and that there will be a transition period where both eCTD and hardcopy CTDs will be accepted prior to eCTDs becoming mandatory.