CTD Module 1
Administrative information and prescribing information for Australia
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 3.0
The following documents provide further information about the regulatory requirements for applications for prescription medicines:
- Prescription medicine registration process. This document provides an overview of the TGA's regulatory processes for category 1 and category 2 applications.
- Mandatory requirements for an effective application
- Questions and answers about the prescription medicines registration process. These pages are updated on a regular basis in response to queries from applicants about the process. Subscribe to the TGA Update email list to receive notifications when the Question and Answers page is updated.
- CTD Modules 2, 3, 4 and 5
- Standards & guidelines for prescription medicines.
|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|