eCTD Validation Criteria

eCTD Validation Criteria

This document is intended to provide requirements to applicants wishing to submit applications for the registration of medicines in eCTD format. It reflects the current situation and will be regularly updated with changes in legislation and experience gained.


Download Version 2 (2.22)

Date updated

2022 Nov

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File Type: pdf
Category: Guideline
Unit: General ECTD & human medicines