Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January 2024, which provides Specifications and guidance for use, V3.1 to compile an eCTD dossier for Australia.
This guidance applies to all regulatory activities in electronic Common Technical Document (eCTD) format and the document replaces AU eCTD specification - Module 1 and regional information Version 3.0 and contains updated information.
The reason behind the update is to provide support for the implementation of the Medicines and Medical Device Review (MMDR) recommendations, including priority, provisions, and notification pathways, as well as the possibility of multiple change requests being submitted in one eCTD dossier.
The other reasons include providing greater clarity to users, enhancing dossier quality, and allowing for automation of some process steps within the TGA.
The document contains:
guidance for compiling an eCTD dossier
specifications for compiling and validating your eCTD regulatory activity.
As part of the upgrade to version 3.1, the following documents and specifications have been updated:
AU eCTD specification Module 1 and regional information
Australian eCTD regional specification and validation criteria, eCTD XML schema and related files
The Module-1 v3.1 of the specification is being reformed and the milestones and updates can be found on the Module-1 v3.2 implementation plan.
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