Transcription of eCTD Guidance Document - Europa
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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.
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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