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Table of Contents
1. INTRODUCTION................................................................................................................................... 1
1.1 BACKGROUND .......................................................................................................................................... 1
1.2 PURPOSE ................................................................................................................................................. 1
1.3 DOCUMENT REVISION AND CONTROL ............................................................................................................ 2
1.4 RELATIONSHIP TO OTHER DOCUMENTS ......................................................................................................... 2
2. GENERAL CONSIDERATIONS.......................................................................................................... 3
2.1 ECTD PUBLISHING..................................................................................................................................... 3
2.2 ECTD SAMPLES ........................................................................................................................................ 3
2.3 TRANSITIONING TO ECTD FORMAT AND RESUBMISSION OF NON-ECTD DOCUMENTS ............................................ 3
2.3.1 Transitioning from Paper to eCTD using us-regional v3.3 ...................................................... 3
2.3.2 Transitioning from us-regional v2.01 to us-regional v3.3 ...................................................... 3
2.3.3 Resubmission of non-eCTD documents .................................................................................. 4
2.4 ECTD LEAF TITLES ..................................................................................................................................... 4
2.5 ECTD SUBMISSION TRACKING AND LIFE CYCLE ................................................................................................ 5
2.6 PRESUBMISSIONS ...................................................................................................................................... 5
2.7 ROLLING SUBMISSIONS ............................................................................................................................... 5
2.8 STUDY TAGGING FILES ................................................................................................................................ 6
2.9 MASTER FILES .......................................................................................................................................... 6
3. ORGANIZATION OF THE ECTD ...................................................................................................... 7
3.1 MODULE 1 – ADMINISTRATIVE INFORMATION AND PRESCRIBING INFORMATION ................................................... 7
3.1.1 FDA Regional eCTD Backbone Files ........................................................................................ 7
3.1.2 Cover Letter and Reviewers Guide ......................................................................................... 7
3.1.3 Patient Experience Data ......................................................................................................... 8
3.1.4 Cross Referencing Previously Submitted Information that is not in eCTD Format ................. 8
3.1.5 Labeling .................................................................................................................................. 8
3.1.6 Advertisements and Promotional Labeling Material ........................................................... 10
3.1.7 Marketing Annual Reports ................................................................................................... 10
3.1.8 Information Amendments .................................................................................................... 10
3.1.9 Field Copy Certification ........................................................................................................ 11
3.1.10 Risk Evaluation and Mitigation Strategy (REMS) ................................................................. 11
3.1.11 Regenerative Medicine Advanced Therapy (RMAT) Designation ........................................ 13
3.2 MODULE 2 – SUMMARIES ........................................................................................................................ 13
3.2.1 Bioequivalence Summary Tables .......................................................................................... 13
3.3 MODULE 3 – QUALITY ............................................................................................................................. 13
3.3.1 Lot Distribution Data ............................................................................................................ 13
3.3.2 Literature References ........................................................................................................... 13
3.3.3 Structure-Data Files ............................................................................................................. 13
3.4 MODULE 4 – NONCLINICAL ....................................................................................................................... 14
3.4.1 Study Reports ....................................................................................................................... 14
3.4.2 Literature References ........................................................................................................... 14
3.4.3 Datasets ............................................................................................................................... 14
3.5 MODULE 5 – CLINICAL ............................................................................................................................. 15
3.5.1 Tabular Listing of All Clinical Studies .................................................................................... 15
3.5.2 Study Reports ....................................................................................................................... 15
3.5.3 Case Report Forms (CRFs) .................................................................................................... 16
3.5.4 Periodic Safety Reports ........................................................................................................ 16
3.5.5 IND Safety Reports ............................................................................................................... 16
3.5.6 Literature References ........................................................................................................... 17