EMA eCTD Validation Criteria 6.0

The eCTD validation criteria v6.0 is now available for public consultation until 14th December 2015. The eSubmission Change Management Board and the Human Harmonisation Maintenance Group (HHMG) would like to invite all pharmaceutical companies, vendors of eCTD building and reviewing tools, and competent authorities to review and comment on the updated validation criteria. The changes are highlighted in the version release notes. Please provide your comments using the comments template to EUM1spec@ema.europa.eu no later than 14 December 2015.

“Validation Criteria 6.0”:http://esubmission.ema.europa.eu/tiges/cmbdocumentation.html

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