This standard format is used to characterize the colour properties from input devices (cameras, scanners), viewing devices (monitors) and finally output devices (colour printers, print processes).

This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based...

Technical Document (CTD) format. • eCTD is the only acceptable format for electronic submissions to CDER and CBER. • Set of PDF documents linked via XML backbone. • Relies on formatted files, hyperlinks and bookmarks for ease of navigation. 2

Provide specific information and recommendations on data types, file sizes and formatting issues. Explain tools available for creating and transmitting an eSubmission. Help avoid common problems before they occur. Provide answers to common questions regarding eSubmissions.

This Controlled Vocabulary Package contains the eCTD v4.0 Code List and associated Genericode files. Note that these documents need to be used in conjunction with the Regional/Module 1 documents provided on each of the regional consultation pages …

information in electronic Common Technical Document format (eCTD) to the National Competent Authorities (NCAs) and the European Medicines Agency (EMA). Also, the guidance aims to be used by the NCAs to harmonise the requirements on eCTD submissions in EU/EEA.

The eCTD indexer is a free and open source program to generate the xml backbones - eu-regional.xml and index.xml required for submission of registration dossiers in the eCTD format. Use of this program requires knowledge of the guidelines linked below and a (very) basic understanding of XML.

This document provides specifications for submitting file format types using eCTD specifications. It is a list of accepted file types and the eCTD locations in which those file types should...

Update made to the Technical Conformance Guide and the Specifications for File Format Types Using eCTD Specifications. Updated ICH STF Stylesheet and Valid Valus xml added. Validation tools...

Apr 12, 2022 · build and/or review the eCTD v4.0 XML Messages and Transition Mapping Messages. • Orientation Material for eCTD v4.0 Implementation Package - Provides an outline of eCTD v4.0 concepts from...