The eCTD validation criteria are a set of standards that must be met in order for an eCTD submission to be considered valid. These criteria are designed to ensure that the submission is complete and accurate and that all required information is included.

The eCTD submission is validation according to the country or region in which the submission is to be submitted to.

To be considered valid, an eCTD submission must meet the following criteria:

  1. The submission must ensure that the file format is correct. This is important because the eCTD submission needs to be in a format that can be read by the regulatory authorities. If the file format is not correct, then the submission may not be accepted.
  2. Ensure that the eCTD submission is complete. This means that all the required documents are included in the correct order; this can be a challenge, as there are a lot of different documents.
  3. The use of file operation of replacing, new, appending and deleting for each file has been used correctly.
  4. The submission must be complete and accurate. Ensure that the submission is free of any errors. This is because errors can lead to the submission being rejected. Therefore, it is important to check and resolve any eCTD validation issues carefully before submitting it to the regulatory authorities.

If any of these criteria are not met, the submission will be considered invalid and will not be accepted.