TIGes Released New Validation Criteria for eCTD (3.0) and NeeS (2.0).
The new validation criteria will come into force 1 September 2011 and be used for the technical validation for electronic submissions received from that day to the NCAs and EMA. The old criteria should no longer apply from that day.
The previous eCTD / NeeS criteria used a priority scale from A to C to categorise the severity of the issue. The decision was made to move to categorising criteria as Pass/Fail and so-called Best Practice.
With new criteria in force, the applicant should make every effort to address P/F and BP before the electronic submission is submitted to the authority. All P/F criteria have to be fulfilled. If any BP criterion is not met it should normally be explained in the cover letter or reviewer's guide.
New criteria, implementation info, release notes:
Even if you already have an eCTD/NeeS solution, why not take a look at eCTD Office and save on time/money with your next e-submission. We'll take only 45 minutes of your time with a web demo of eCTD Office.