Updated EU eCTD Validation Criteria

The European Medicines Agency (EMA) updated version 7.1 EU eCTD Validation Criteria will come into force September 1, 2018.  The changes in the validation criteria relate mainly to change requests received from regulatory bodies and taking experiences with version 6.1 into account.  Click here for the Release Notes for the EU eCTD Validation Criteria version … Continued

Back to top