The Therapeutic Goods Administration (TGA) of Australia has released an updated version of its electronic Common Technical Document (eCTD) Module 1 Specifications, moving from version 3.1 to 3.2. This new specification will officially come into effect in April 2025, marking a significant step forward in regulatory submission alignment and technical clarity.
Key Highlights of Version 3.2:
- Amendments to Defined Lists and Matrices: Enhancements to both the sequence and document matrices improve consistency and traceability across submissions.
- Revised Validation Criteria: The updated validation rules provide clearer expectations and reduce the risk of errors during submission.
- Refinement of Heading Elements in Module 1: Headings have been adjusted for greater precision and usability.
- Expanded File Format Support: New allowances for file types such as .txt and .doc, increasing flexibility in documentation formats.
- New Rules for Work-sharing and Partial Withdrawals: These additions streamline collaborative submissions and enable more efficient regulatory processes.
A six-month transition period will allow for the use of either version 3.1 or 3.2 until October 31st, 2025, after which only version 3.2 will be accepted.
For detailed guidance and full documentation, please refer to the official TGA website.
How ASPHALION Can Help
At Asphalion, we are fully prepared to assist our clients in adapting to these changes. Whether you are transitioning your systems, preparing submissions, or seeking strategic regulatory advice, our team is ready to ensure your eCTD processes remain compliant and efficient.
If you need support with your eCTD submissions or regulatory strategy, contact us at [email protected]
