We’re excited to inform you about the major release of version 25.06 of EXTEDO’s eCTD Manager and EURS Validator, which includes key regulatory updates and improvements to ensure continued compliance and enhanced usability across global markets.
Below is a summary of the most relevant updates:
eCTD Manager 25.06 Major Release Highlights
- Tunisia (TN): Support for the new RST (Regulatory Standard) for eCTD v1.1
- Study Tagging Files (STF): Now supporting valid values version 6.0
- Canada (CA): Updated default node extension export type for eCTD v2.2 modules M4 and M5 to ‘XML instance and Directory Structure’
EURS Validator 25.06 Major Release Highlights
- Tunisia (TN): Implementation of validation criteria for eCTD v1.1
- Bug fixes applied to improve performance and accuracy in:
- Europe (EU)
- Canada (CA)
- South Africa (ZA)
- Taiwan (TW)
Looking Ahead: What’s Coming in Version 25.07 (Expected End of July)
EXTEDO is already preparing the upcoming 25.07 release, expected later this month. Anticipated updates include:
- Egypt (EG): Support for the new RST for eCTD v1.0
- European Union (EU): Update to VNeeS v3.2 format for veterinary registrations
What Should You Do Next?
If these changes affect your region or regulatory activity, we strongly recommend updating your tools to version 25.06.
You can access the release notes and download the latest version through your myEXTEDO Customer Portal.
Need support with the update or implementation?
Asphalion is here to help. Contact our experts at [email protected] and we’ll be happy to assist you.
