The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU Module 1 and Regional Information document. This guide provides the specifications and guidance for submitting regulatory information electronically to the TGA using the electronic Common Technical Document (eCTD) format.
electronic Common Technical Document - an electronic standard for the Common Technical Document (CTD) providing the means for transferring information from pharmaceutical companies to agencies. The AU Module 1 contains administrative and region-specific information required for TGA submissions, supplementing the internationally harmonized Modules 2-5 of the eCTD. This version, v3.2, outlines the specific requirements for Australian submissions and provides detailed guidance on how applicants should structure and submit their documents.
This guide contains:
guidance for compiling an eCTD dossier
specifications for compiling and validating your eCTD regulatory activity.
This guidance replaces AU eCTD specification – Module 1 and regional information Version 3.1 and contains updated information. Version 3.2 of the specifications and validation criteria will come into effect in February 2025 with a 6-month transition period and should be read in combination with the summary of updates and the supporting technical documentation mentioned in this guidance.
Timelines for implementation of version 3.2
The AU eCTD version 3.2 specification will be effective starting 1 February 2025.
The AU eCTD version 3.1 specification will be accepted until 31 July 2025.
The AU eCTD versions 3.0 or earlier are no longer accepted.
If the sequence is less than 100Mb and you have it ready by the time you complete the online pre-submission application form, you can upload it as a zip file directly into the form but If the file size is small enough to attach to an email, it needs to be emailed it to esubmissions@health.gov.au. For large file transfers please contact esubmissions@health.gov.au to discuss options.
As defined by the ICH eCTD Specification Document- external site, TGA will also accept PDF, XML, and MS Word Forms. Currently, there are no structured exchange standards for content, though they may be introduced in the future for content such as the lifecycle management tracking table, application forms, product information, etc. And where possible, generate PDFs from electronic sources.
The TGA’s eCTD AU Module 1 and Regional Information v3.2 specification and guidance are essential for anyone involved in submitting regulatory applications to the TGA. The document provides critical updates and instructions on how to compile and submit region-specific information to ensure compliance with Australian regulatory requirements. For full details and to access the guidance document, visit the TGA's official page.
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