The Telematic Implementation Group for electronic submission and ICH Implementation(TIGes) has published additional clarification on the draft eCTD validation criteria 3.1 as published earlier this year (see our related News article).The additional clarification concerns the validation checks that require the presence of the previous eCTD lifecycle sequences to be performed correctly.
The first key message included in the clarification document is that "the revised criteria for technical validation of eCTD sequences (v3.1) should be treated as a single complete set of tests and not be divided in any way."
For More Information please click: EMA New Validation Criteria (3.1)
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