eCTD submission

US FDA will be accepting eCTD submission with U.S. Regional DTD V3.3 only from 1st March 2022

The US Food and Drug Administration’s (FDA or Agency) has announced the date that they will no longer support electronic submissions using the Electronic Common Technical Document (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 after March 1, 2022. And They will only accept eCTD submission with U.S. Regional DTD V3.3 only from 1st March 2022.
FDA is issuing this Federal Register notice pursuant to the guidelines described in the FDA guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act” (December 2014, available at https://www.fda.gov/media/88120/download), section III.F “When will revisions or updates to existing formats take effect?” to announce the end of support for electronic submissions using eCTD Module 1 U.S. Regional DTD V2.01 and the date the requirement begins to submit using eCTD Module 1 U.S. Regional DTD V3.3 as described in this notice. Due to the limitations of eCTD Module 1 U.S. Regional DTD Version 2.01, FDA support for electronic submissions using eCTD Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional DTD V2.01, and U.S. Regional Stylesheet Version 1.1 will end on March 1, 2022. The requirement for electronic submissions to be submitted using eCTD Module 1 U.S. Regional DTD V3.3 will begin on March 1, 2022. The Agency will update the eCTD Submission Standards document to reflect these changes. For More Information refer below link. https://www.regulations.gov/document?D=FDA-2018-D-1216-0017

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