eCTD Guidance Document - eSubmission - Europa

Table of Contents
1. INTRODUCTION ................................................................................................................................ 3
1.1 Glossary ....................................................................................................................................... 4
2. GENERAL CONSIDERATIONS ....................................................................................................... 5
2.1 Scope ........................................................................................................................................... 5
2.2 Structure of Submissions ............................................................................................................. 5
2.3 Transitional Arrangements .......................................................................................................... 6
2.4 Moving to eCTD Format from Paper or NeeS Type Applications .............................................. 6
2.5 General Submission Considerations ............................................................................................ 7
2.6 Correspondence ........................................................................................................................... 7
2.7 Paper Requirements ..................................................................................................................... 7
2.8 Hardware ..................................................................................................................................... 8
2.9 General Technical eCTD Information ......................................................................................... 8
2.10 Other Technical Information ..................................................................................................... 13
2.11 Number of Media Requested ..................................................................................................... 15
2.12 Technical Baseline Applications ............................................................................................... 15
3. MODULE SPECIFIC INFORMATION .......................................................................................... 19
3.1 General Information .................................................................................................................. 19
3.2 Module 1 eCTD Envelope, Administrative Information and Prescribing Information Folder . 19
3.3 Module 2 Overviews and Summaries Folder ............................................................................ 21
3.4 Module 3 Quality Folder ........................................................................................................... 22
3.5 Module 4 Nonclinical Study Reports Folder ............................................................................. 22
3.6 Module 5 Clinical Study Reports Folder ................................................................................... 22
4. ADVICE ON SPECIFIC APPLICATION TYPES ......................................................................... 24
4.1 Initial MA Applications ............................................................................................................. 24
4.2 Variation Applications .............................................................................................................. 25
4.3 Extension Submissions .............................................................................................................. 26
4.4 Renewal Submissions ................................................................................................................ 26
4.5 PSURs ....................................................................................................................................... 27
4.6 MRP and DCP Applications ...................................................................................................... 27
4.7 Referrals .................................................................................................................................... 27
4.8 Active Substance Master Files .................................................................................................. 28
4.9 Vaccine Antigen Master Files ................................................................................................... 28
4.10 Plasma Master Files .................................................................................................................. 28
4.11 Applicant Initiated Withdrawals ............................................................................................... 29
4.12 Duplicate Applications .............................................................................................................. 29
ANNEX 1: ECTD REFERENCE DOCUMENTS ............................................................................................. 30
ANNEX 2: GUIDANCE ON TEXT SEARCHABLE DOCUMENTS ................................................................... 31
A2-1 General ...................................................................................................................................... 31
A2-2 Documents that Must Always Be Text Searchable ................................................................... 31
A2-3 Documents that Do Not Need to Be Text Searchable ............................................................... 32
A2-4. Further Information ................................................................................................................... 32
ANNEX 3: GUIDANCE AND BEST PRACTICE ON THE STRUCTURE OF MODULE 3 .................................. 33
A3-1. Introduction ............................................................................................................................... 33
A3-2 General Principles ..................................................................................................................... 33
A3-3 Module 3 XML Attributes in the eCTD .................................................................................... 36
Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD
Version: 2.0, August 2011
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