The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Introduction
We are working in collaboration with industry partners to reform our existing eCTD AU Module 1 and Regional Information – specification and guidance for use v3.1 (Module-1 v3.1) to ensure our regional requirements are fit-for-purpose and align with current business needs.
The purpose of the update from Module-1 v3.1 to v3.2 is to enhance dossier quality and provide greater clarity to users by:
- Amending the defined lists and matrices to ensure they align with current business processes and incorporate flexibility to adapt to future needs.
- Reviewing the Australian eCTD validation criteria to ensure they provide clear and consistent requirements.
- Amending eCTD AU Module 1 heading elements to ensure they are descriptive, accurate, and comprehensive.
An updated technical specification and guidance for use (Module-1 v3.2) has been published.
Full specification: eCTD AU Module 1 and Regional Information v3.2
Summary of changes: eCTD AU Module 1 v3.2 Summary of changes
Module-1 v3.2 is to be used in conjunction with ICH eCTD Specification v3.2.2 - external site for the electronic submission of regulatory information relating to all Prescriptions Medicines.