TGA has announced updates to Module 1 & Regional Information to the specifications and technical validation criteria transitioning from eCTD AU Module-1 v3.1 to v3.2.
Transition Timeline: AU Module 1 Version 3.2 specification will be effective starting April 2025. AU Module 1 Version 3.1 specification will be accepted until October 2025. Between April and October 2025, the TGA will accept both the Version 3.1 and Version 3.2 AU Module 1 specifications. Purpose of Updates:These updates aim to align with business processes, revise validation criteria, and improve document organization within eCTD applications and Improve document organization within eCTD applications.
Supporting Documents:The update includes technical files like schemas, stylesheets, and codes/defined lists for compliance. Detailed information can be found on the TGA website: here.
This update aims to streamline processes, enhance clarity, and ensure better organization within eCTD applications.
Masuu Global offers comprehensive services for navigating the AU-TGA eCTD submission updates. The TGA has announced changes to Module 1 & Regional Information, transitioning from eCTD AU Module-1 v3.1 to v3.2. The updated specification (v3.2) becomes effective in April 2025, with v3.1 accepted until October 2025. The updates aim to streamline processes, revise validation criteria, and improve document organization. Masuu Global supports clients in complying with these changes by offering guidance on technical files and resources. Detailed information is available on the TGA website.
