Zdrowie i gospodarka · 06/08/2012
Documents to Support Submission of an Electronic Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of the following final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: "The eCTD Backbone Files Specification for Module 1, version 2.0" (which includes the U.S. regional document type definition (DTD), version 3.0) and "Comprehensive Table of Contents Headings and Hierarchy, version 2.0." Supporting technical files are also being made available on the Agency Web site. These documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information. FDA is not prepared at present to accept submissions utilizing this new version because eCTD software vendors need time to update their software to accommodate this information and because its use will require software upgrades within the Agency. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.0 by September 2013, but this is not a firm date and we will give 30 days advance notice to industry.