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CTD Module 1
Administrative information and prescribing information for Australia - Applicable to applications received by the TGA from 9 February 2018
Module 1 of the CTD describes the administrative information and prescribing information (for example, the application form, the proposed product information and labelling) for Australia to support:
- the registration of a prescription medicine under section 23 of the Therapeutic Goods Act 1989 ('the Act')
- the variation of the details of an ARTG registration for a prescription medicine under section 9D of the Act.
- explains the format and content for Module 1 of a dossier
- describes each document in Module 1
- outlines when each document needs to be provided
- details any other requirements relating to the documents.
Dossier document matrix
- A summary of CTD document requirements for applications to the TGA is shown in the eSubmission Document matrix, available at: Australian eCTD regional specification and validation criteria .
The following documents provide further information about the regulatory requirements for applications for prescription medicines:
- Prescription medicines registration process. This document provides an overview of the TGA's regulatory processes for category 1 and COR report-based applications.
- Priority review registration process. This document outlines the key differences between this process and the prescription medicines registration process.
- Mandatory requirements for an effective application.
- CTD Modules 2, 3, 4 and 5.
- Standards & guidelines for prescription medicines.
- Variations to prescription medicines – excluding variations requiring evaluation of clinical or bioequivalence data.
|Version||Description of change||Author||Effective date|
|V1.0||First version||Office of Medicines Authorisation||28/09/2007|
|V2.0||Second version to reflect outcomes from the public and stakeholder consultation and the revised prescription medicine registration process.||Office of Medicines Authorisation||16/05/2013|
|V2.1||Editorial amendments||Office of Medicines Authorisation||30/05/2013|
|V2.2||Alignment with revised PPF, editorial changes.||Office of Medicines Authorisation||30/04/2014|
|V2.9||Revisions to align with introduction of eCTD format||Office of Medicines Authorisation||05/09/2014|
|V3.0||Third version to reflect electronic dossiers||Medicines Authorisation Branch||01/07/2015|
Updated to include
|Prescription Medicines Authorisation Branch/Scientific Evaluation Branch||09/02/2018|
|V4.1||Updated to remove 'minor' from variations||Prescription Medicines Authorisation Branch/Scientific Evaluation Branch||July 2019|