EU Publishes Updated Validation Criteria

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Today, EMEA posted an updated version of EU eCTD Validation Criteria (V2.1) on their eSubmissions: What’s New page.

Changes are minor and include:

  • Introduction of new check 11: “The checksum of the index.xml, when calculated by the validation tool, should match the checksum provided in the index-md5.txt” [This is pretty straightforward and was already being checked at the FDA.]
  • Change in the category of check 10 “The regenerated checksum for every referenced file is the same as each associated checksum provided in the backbone file (e.g. eu-regional.xml)” from A (Serious) to C (Low). [This in general appears to support a trend in regulatory agencies not placing much importance on checksums – possibly based on the fact that external tampering with eCTDs submitted to an authority is highly unlikely either with gateway submissions or hard media submissions.]
  • Re-numbering of existing checks 11-44 based on the introduction of new check 11
  • Replacement of reference to EU DTD 1.2.1 with 1.3

Overall, the comment was that the criteria were updated “to explicitly support EU M1 v1.3 and to include a new criterion no.11 on the calculation of the checksum.”

Author: GS

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