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U.S. Department of Health and Human Services

Drugs

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eCTD Validation Specifications

Validation is an important processing component in order to ensure compliance with the eCTD specification and improve the availability and reviewability of individual submissions and applications throughout their lifecycle.

Following are FDA's current Validation Specifications.  Please note that these specifications support Valid Values v3.0. 

For your convenience, an XLS version of this document is being provided in addition to the PDF version.


The following version supports making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications using "The eCTD Backbone Files Specification for Module 1," version 2.2.  FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.3 by 4th Quarter 2014, and will give 30 days' advance notice to industry before this version is implemented. 


In addition to the validation criteria specified in the current Validation Criteria document, FDA may perform additional validation checks for both eCTD and non-eCTD submissions. These validation checks are intended to ensure that submissions are processed and routed accurately and in a timely fashion. The additional validation checks include:

  1. Ensuring that the application form submitted matches the application type specified in the us-regional.xml file, e.g., the us-regional.xml specified application type is NDA but the sponsor has submitted a 1571.
  2. Ensuring the consistency of the application number specified in the us-regional.xml file and application form.

Additional information on submissions that do not pass the Agency’s validation checks may be found in  Guidance for Industry Providing Regulatory Submissions in Electronic Format — Receipt Date [PDF]