Could you mention some reasons why validation reports results may differ between NCAs and the Applicants?
In some cases the validation report results have been different even though Fimea and the Applicant have used the same validation tool. We have noticed that some times the Applicant has validated the data in their own document management system and, therefore, validated data is not identical to the CD/DVD sent to Fimea. To ensure that both parties are validating exactly the same data, please, validate the actual burned CD/DVD media before sending it to NCAs.
Can you please advice if there is an eCTD validator/checker tool available? As we will like to ensure there are no errors before we submit.
We know two vendors offering free validator tools that include required EU eCTD and NeeS validation criterias. These vendors have also developed eCTD review tools that are used by many NCA in Europa. Fimea uses Extedo’s validator “EURS is Yours”.
For more information click here: Fimea (Finnish Medicines Agency) - Updates on Frequently asked questions about electronic submissions
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