Transcription of eCTD Guidance Document - Europa
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eCTD Guidance Document - Europa
Page 1 of 60 Guidance for Industry on Providing Regulatory Information in Electronic Format Harmonised Technical Guidance for ectd Submissions in the EU Version August 2013 Technical ectd Guidance Page 2 of 60 Table of Contents Table of Contents .. 2 List of Tables .. 4 List of Figures .. 4 1. INTRODUCTION .. 5 Glossary .. 6 2. GENERAL CONSIDERATIONS .. 7 Scope .. 7 Structure of Submissions .. 7 Transitional 8 Moving to ectd Format from Paper or NeeS Type Applications .. 8 General Submission Considerations .. 9 Correspondence .. 9 Paper 10 Hardware .. 10 General Technical ectd Information .. 10 Other Technical Information .. 16 Number of Media Requested.
This guidance document is intended to assist pharmaceutical companies with the submission of regulatory information in electronic Common Technical Document format (eCTD) to the National Competent Authorities
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