Transcription of eCTD Guidance Document - Europa
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eCTD Guidance Document - Europa
Guidance for Industry on Providing Regulatory Information in Electronic Format: ectd Version: , August 2011 1 (46) Guidance for Industry on Providing Regulatory Information in Electronic Format TIGes Harmonised Guidance for ectd Submissions in the EU Version August 2011 This Document is published under the auspices of the EU Telematics Implementation Group - electronic submissions (TIGes) Guidance for Industry on Providing Regulatory Information in Electronic Format: ectd Version: , August 2011 2 (46) Table of Contents 1. INTRODUCTION .. Glossary .. 42. GENERAL CONSIDERATIONS .. Scope .. Structure of Submissions .. Transitional Arrangements .. Moving to ectd Format from Paper or NeeS Type Applications .. General Submission Considerations .. Correspondence .. Paper Requirements .. Hardware .. General Technical ectd Information .. Other Technical Information .. Number of Media Requested .. Technical Baseline Applications.
Technical Document (CTD), and relevant ICH and EU Q&A documents. The structure and organisation of an eCTD submission is defined by the following standards: • ICH M2 eCTD Specification • EU Module 1 Specification • Relevant ICH and EU Q&A docs . Annex 1 contains links to the currently approved version of these documents.
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