eCTD Validation Criteria Severity: What High, Pass/Fail and Error Mean at Each Agency

Every agency publishes eCTD validation criteria, and every agency grades them differently. A “warning” in one region is not the same as a “medium” in another. Knowing which grades stop a submission is the difference between a clean filing and a technical rejection.

Why severity matters more than count

eCTD validation criteria are the checks an agency runs automatically when a sequence arrives. Each criterion has an identifier, a description of what it checks and a severity. The severity decides what happens when the check fails: whether the sequence is rejected outright, accepted with a request to correct it, or accepted with a note.

Because each agency writes its own criteria, the grading schemes differ. A team that files in several regions needs to read each report in that region’s terms. Below is what the main schemes mean, with the number of criteria in each set as published.

FDA: high, medium and low

For eCTD 3.2.2, FDA grades each criterion high, medium or low. A high finding means FDA will reject the submission on technical grounds: it is not filed and the review clock does not start until a corrected sequence arrives. A medium finding may need corrective action, and FDA will contact you if it does. A low finding should be corrected in future submissions. Of FDA’s 150 v3.2.2 criteria, 45 are high severity.

For eCTD 4.0, FDA publishes a separate set because the message format, controlled vocabularies and lifecycle model are different. Those criteria are graded High Error or Warning: a High Error stops the submission, a Warning is reported but does not. Of the 144 v4.0 criteria, 103 are High Error — a much larger share than in 3.2.2, which is worth knowing before a first 4.0 filing.

The full FDA list, searchable and filterable by severity, is on our FDA eCTD validation criteria page.

EU and WHO: pass/fail and best practice

The EU criteria are binary in effect. A sequence that fails any pass/fail criterion is rejected on technical grounds and must be resubmitted. Best practice criteria do not cause rejection, but their findings are visible to the assessor and should be corrected. WHO Prequalification follows the same model. See the EU criteria and WHO PQ criteria.

Health Canada and SAHPRA: error, warning, information

Health Canada grades each rule as error, warning or information. An error means the regulatory transaction fails validation and must be corrected and sent again. A warning should be fixed but does not stop processing on its own; information findings are for awareness. South Africa’s SAHPRA uses the same three grades with the same meaning. See the Health Canada and SAHPRA lists.

A clean report only means something if it was graded the way the receiving agency grades it.

Three practical rules

• Validate at the agency’s severity. A tool that maps every region onto one generic scale will tell you a finding is “minor” when the agency treats it as a reason to reject.
• Keep the criteria current. Agencies revise their criteria; FDA, for example, versions its v4.0 set. Check that your validator runs the version in force on the day you submit.
• Do not ignore the lower grades. Medium, warning and best-practice findings do not stop a sequence, but reviewers see them, and they tend to repeat in every later sequence until someone fixes the source.

How DnXT approaches it

DnXT Publisher applies each region’s own criteria at that region’s own severity — more than 2,500 criteria across 16 eCTD regions, including both FDA sets — while a sequence is assembled. The published lists above come from the same rule library the software runs.