As this revision history proves, the FDA updates its specifications for eCTD validation criteria continually, a fact that makes it extremely difficult to keep up with the changes and so easy to miss an update. Whilst eCTD submission specialists like us are here to bridge the gap between organisations preparing eCTD documents and the authorities receiving them, recurrent eCTD validation criteria changes mean eCTD validation issues are particularly common.
To help you identify the most common eCTD validation issues, and more importantly avoid them, we’re here to highlight the most frequently seen validation issues and how to fix them!
Understanding eCTD validation criteria
Put simply, eCTD validation criteria is a set of standards that must be adhered to to ensure your eCTD documents are deemed ‘valid’. The simplest deviation from these criteria can make your eCTD submission invalid, which would mean timely and costly resubmission.
Validation criteria varies from health authority to health authority, and can even differ depending on the country or region that the eCTD documents are being submitted to.
Common eCTD validation criteria issues
Formatting is one of the most common areas of validation criteria issues. Without applying the right portable document format specifications for your eCTD submission, eCTD documents can be rejected on technical grounds.
An eCTD submission that is deemed ‘incomplete’, i.e. lacking specific information, is another common validation criteria problem that many organisations encounter. Your eCTD submission may be marked as incomplete if the documents are not supplied in a specific order. Amending submitted files also comes with its problems. File operation is vital for the replacement, addition or deletion of individual files, but must be used correctly. The accuracy of your eCTD submission is another vital consideration.
Consistency is also key, particularly when it comes to the person authorised for communication mentioned throughout an eCTD submission or Marketing Authorisation Application (MAA) as EMA details:
“The person authorised for communication on behalf of the applicant should be consistent throughout the eAF (on the declaration and signature page, and in section 2.4.2) and in Annex 5.4. Please also note that personalised email addresses are required for eAF sections 2.4.1, 2.4.2 and 2.4.3. In addition, contacts listed under these sections should be duly registered in the EMA Account Management Database.”
Solving validation criteria problems
Understanding the latest validation criteria and associated issues before submission is essential and should always be your starting point. Utilise the latest version of eCTD validation software to resolve eCTD errors.
Validation software will produce error codes to ensure that the eCTD documents are being composed in accordance with the current eCTD sequence, meaning you can address the issue at hand.
Using an eCTD submission management service like ours will ensure the highest chance of success when submitting to EMA, MHRA, FDA, Health Canada, Swissmedic, Australia, ASEAN GCC, SAHPRA/MCCZA, EAEU and the rest of the world.
We actively support clients with technical validation, formatting and publishing to deliver compliant submissions that meet the organisation’s own stringent standards as well as the strict validation criteria set by health authorities.
Please contact us today to find out more about our eCTD submission management services or to discuss your requirements.
