Extedo has released new updates of the eCTDManager® and EURSValidator® tools. These updates are of particular relevance, as they include the new EU eCTD v3.1 Module 1 Specifications and EU Validation Criteria 8.1
On June 18, 2024, v3.1 of the eCTD M1 specifications for Europe was published alongside with the new v8.0 of the validation criteria. Subsequently, a minor update was recently released on October 28th, 2024, to v8.1 of the validation criteria.
During the initial 6-month transition period, from June 18th, 2024, to November 30th, 2024, applicants will only be able to submit documents in eCTD format that comply with EU M1 v3.0.4 and validation criteria v7.1.
- From December 1st, 2024: eCTD submissions will be accepted in EU M1 v3.0.4 or v3.1 format, and validation criteria v7.1 or v8.1 will be acceptable.
- From March 1st, 2025: Only eCTD submissions in EU M1 v3.1 format with validation criteria v8.1 will be accepted.
Therefore, this update is mandatory to continue publishing in the European eCTD format from March 1st, 2025. Please consider adaptation timeframe for this new format, to plan your tool updates and validations well in advance the final deadline.
For more information on the new EU updates, please refer to EMA eSubmission website. https://esubmission.ema.europa.eu/eumodule1/index.htm
Moreover, please take into account that there is an uncertainty about the aforementioned EU updates applicability in the UK. MHRA is already working on providing further guidance on this regard. Until this happens, our recommendation is to keep applying current EU specifications and validation criteria.
eCTDManager® 24.10 HF1
In addition to the adaptation to the new EU eCTD Module 1 Specifications v3.1 (DTD 3.1), this update also includes some improvements, new functionalities and bugs corrections, as below:
- Cross Application References in Submission Grouping (FDA)
- EXTEDOpulse® enhancements
European dossier upgrade to v3.1 can be carried out with the “upgrade” function in eCTDManager® at the moment of publishing your next subsequent eCTD sequence in a European dossier. For carrying out such an upgrade, please take into account the aforementioned implementation periods.
EURSValidator® 24.10 HF2
A new version is also available, supporting EU eCTD Validation Criteria v8.1. As with eCTDManager®, this update is necessary for the continuation of the life cycles of European dossiers, according to the timeframes set out above. Even if you don’t have the standalone EURSValidator® tool, it’s still essential to keep the validation libraries in eCTDManager® up to date.
This version also includes updated versions (because of bugs reported) of AU eCTD 3.1, CN eCTD 1.0 and EU v7.1 Validation Criteria.
All the new features in detail, as well as the complete documentation, of the new version and the links for downloading, are available at My Extedo Portal myEXTEDO Customer Portal.
First Level Support
Also, we would like to remind you that Asphalion is a Extedo’s First Level Support provider. At no additional cost, this service provides assistance with troubleshooting issues (i.e., errors or warnings on import, export and validation, rejections by regulatory authorities, information on access, maintenance and configuration, information on updates, etc.).
In addition, you can contact us if you have any needs regarding Extedo’s products, such as modifications or extensions of your licenses, need for new tools, or commercial questions. If you are interested, we can hold a personalized meeting to evaluate possible current or future needs.
If you need help from Asphalion with these updates, tool validation, etc., do not hesitate to contact our Regulatory Operations team at: [email protected]
