Marketing Authorisation Holders beware!

The FDA has just announced that the Center for Drug Evaluation and Research (CDER) will begin rejecting submissions that fail eCTD validation checks 1551 and 1553. Both validation errors are of high severity as described in the eCTD Validation Criteria specification. The different severity levels can be summarised as follows:

  • High: The error is a serious technical error which prevents the processing of the submission and will require resubmission. The submission is considered not received by FDA.
  • Medium: The error may impact the reviewability of the submission but cannot be determined without further inspection by the review staff. The submission might be considered received by FDA.
  • Low: The error is a technical error which may or may not impact the reviewability or the integrity of the submission. The submission will likely be considered received by FDA.

And time is up!

As announced in the Federal Register Vol. 86, No. 165, CDER will begin to reject marketing authorisation applications in eCTD format that fail to pass either eCTD validation 1551 or 1553 from 18/October/2021.

What are validation errors 1551 and 1553?

eCTD validation error 1551 is about missing Product Labelling information that sponsors have to provide in Module 1.14.6 for 2253 submissions. Sponsors are required to submit the most up to date labelling information under 21CFR314.81(b)(3)(i). Please note this is valid for US DTD version 3.3.

eCTD validation error 1551

eCTD validation error 1553 is about FDA Form 2253. MAHs are required to submit Form 2253 for Submission Type of “Promotional Labelling”. Other Forms are not permitted under this Submission Type. Please note this is valid for US DTD version 3.3.

eCTD validation error 1553

In summary

Marketing Authorisation Holders have to take this FDA notice seriously as CDER will start to reject applications in eCTD format that do not conform with validation criteria 1551 and 1553.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

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