FDA upgrades eCTD environment

By on Wednesday, July 19, 2017 in Industry Updates

FDA upgrades eCTD environment to newest version of GlobalSubmit VALIDATE

The US Food and Drug Administration (US FDA) has upgraded their GlobalSubmit VALIDATE™ suite as of July 10th, 2017 implementing the new eCTD validation criteria for Study Data Technical Conformance.

This upgrade focuses on new eCTD validation changes, including new High Level validation errors including those for dataset validation. If high errors are found, submission(s) will receive a technical rejection and will not be filed with the FDA.

Highlights include:

  • 19 new PDF annotation errors 5062-5082 for Module 1.15
  • Dataset validation errors 1734-1737 for studies in NDA’s, ANDA’s, and BLA’s, starting after December 17, 2016, these errors will not apply for studies before that date. These errors will be effective for IND’s starting after December 17th, 2017
  • Corrected an issue causing VALIDATE to produce a High 2012 error when a checksum was missing from a Module 1 document

Since June 2005, the FDA has solely utilized GlobalSubmit REVIEW™ & GlobalSubmit VALIDATE™ solutions and this partnership was recently extended.

Synchrogenix remains committed to being a transparent and trustworthy partner. We will continue to create best in class eCTD review and validation software and provide updates as we continue our partnership with the US FDA.

Post a Reply

Your email address will not be published. Required fields are marked *