US FDA announced the requirement for Electronic Common Technical Document (eCTD) Module 1 U.S. Regional DTD Version 3.3 starting from 01 March 2022.

Electronic submissions by way of the eCTD Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01 will no longer be supported.

The updated requirements go into effect on 01 Mar 2022.

Electronic and written comments are allowed to be made at any time before the requirements go into effect. Electronic comments may be made through the Federal eRulemaking Portal. For written and paper comments, please use the following address: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

To ensure effortless compliance, use our eCTDmanager to build, view, validate and publish your electronic and paper submissions. eCTDmanager gives you a comprehensive overview of your submission statuses across products, helping you ensure compliance across multiple countries, requirements, and conditions.

For your validation needs, seek out EURSvalidator. Used by over 35 regulatory agencies around the world, it is the industry’s most reputable technology for eCTD compliance. For more information, please visit the Federal Register’s Website. If you have any further questions, don’t hesitate to contact us.


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