CTD Module 1

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.

This guidance:

• 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.

Further information

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 .

Regulatory requirements

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.