eCTD Validation Criteria by Region: Every Agency Rule, Explained
eCTD validation criteria, region by region
Every health authority publishes the technical checks a sequence must pass before review begins. These pages put each region’s criteria in one searchable place, in plain language, with the fix for every rule.
Criteria by health authority
Each page is generated from the criteria DnXT Publisher runs, so it reflects what is actually checked.
Canada (Health Canada)
145 criteria with severity, what each checks, and how to fix it.
Open the criteria →European Union
111 criteria with severity, what each checks, and how to fix it.
Open the criteria →United States (FDA)
294 criteria with severity, what each checks, and how to fix it.
Open the criteria →WHO Prequalification
87 criteria with severity, what each checks, and how to fix it.
Open the criteria →South Africa (SAHPRA)
197 criteria with severity, what each checks, and how to fix it.
Open the criteria →Technical validation comes before review
Before a reviewer opens a single document, the agency’s system checks the backbone, envelope, files and lifecycle against that region’s criteria. A failure at the highest severity stops the submission, and the review clock does not start.
The same defect can be a warning in one region and a rejection in another, so a sequence should always be checked against the target authority’s own criteria at its own severity. DnXT Publisher does that for 16 eCTD regions and more than 2,500 criteria, while the sequence is being built.
Frequently asked
Where do these criteria come from?
Each region’s page summarises the health authority’s published validation criteria. The agency’s own documents are authoritative; always confirm against the current version before relying on a single rule.
Validate against every region you file in
See DnXT Publisher check a sequence against the target authority’s criteria while it is being built.
