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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 for the electronic submission of regulatory information relating to all Prescriptions Medicines.