What to expect? Changes in regulatory operations
The following notable changes are included within the eCTD M1 v3.0 standard:
- Additional submission types will be introduced support specific regulatory activities (e.g. submission of clinical study reports redacted for publication to the EMA, applications for Certificates of Suitability directed to the EDQM, etc.)
- The “submission type” attribute will be used to describe regulatory activities such as responses to questions from agencies or update due to validation issues.
- A UUID field will be introduced - all eCTD sequences built in accordance with the revised specification must contain a Universal Unique IDentifier, linking the sequence to the eCTD application to which it belongs.
- Various changes for standard terminologies and standard values.
How to prepare? Contact your vendor
It is highly likely that your eCTD software solutions and validation tools will need to be updated in order to accommodate these new requirements. If you have not already done so, we strongly advise contacting your vendor to ensure your solution is compliant.
As the partner of choice to over 80% of regulatory agencies around to world, EXTEDO is well prepared and our transition to eCTD M1 v3.0 is already well underway. EXTEDO’s EURSvalidator is used by regulatory authorities across the world, including the European Medicines Agency (EMA), to ensure that eCTD submissions comply with defined standards. The latest release of EURSvalidator is the first commercial validation solution to support the new standard, with all regional validation sets now being fully eCTD M1 v3.0 compliant.
Our team is prepared to answer any questions you might have regarding the new regulatory specifications, and ensure you have a smooth and timely transition to version 3.0.