As some of you may already know, the European region is going to put new validation criteria into effect in September 2011.
The new criteria can be found on the eSubmission web site at the following link: http://esubmission.emea.europa.eu/
European Region Impact on Validation Tools and eCTD Validation
For one, the previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.
For the Pass/Fail checks, any eCTD that fails to pass all checks will be returned to the applicant for fixing and resubmission. Additionally, according to the new criteria, the Best Practice checks are now strongly recommended.
From the Best Practice description found in the Validate Criteria 3.0 document:
“The applicant should make every effort to address these areas before the eCTD is submitted to the agency. The applicant should be prepared to include justification for any Best Practice criteria not met in the submission cover letter/reviewer’s guide.”
The most critical point to take away from this change to the priority levels is that now all tests must pass. Yes, eCTDs that fail to pass Best Practice checks will be accepted during technical validation, and may not even be checked, but based on the previous statement, it is clear that the European authorities are really pushing for clean eCTD submissions.
Another item new to the criteria is an indication that a validate check can only be performed in the context of other eCTDs in the lifecycle. This indication has been set on checks which relate to operations and submissions in other sequences. For example, “11.9: The leaf referenced by the modified file must exist in a previously submitted sequence within the same eCTD application”. If you were only validating one sequence that has a leaf modifying a leaf in a different sequence, then this check could not be fully completed unless the other sequence was present during the validation. In this case, validation tools should indicate if the other sequence was present or not when the checks were done.
Impact on GlobalSubmit VALIDATE?
GlobalSubmit will map all Pass/Fail checks to High severity, which is essentially priority A from the EU Validation Criteria V2.1. We will also take all Best Practice checks and assign them a Medium severity.
For the checks which can only be performed in the context of other eCTDs, the VALIDATE tool will always perform all checks based on all currently loaded sequences in the application. If the modified file exists in an unloaded sequence, an error will be reported indicating that the modified file is missing.