Because the eCTD is based on the ICH CTD, my next few posts will cover the content in each of the specific CTD modules. Module 1 contains the region-specific information and is the only module that will vary based on where the application will be submitted. The other modules won’t change from region to region. Examples of region-specific documents include the specific application forms as well as labeling and prescribing information. This module provides each region with the flexibility to adapt the submission package to meet the local legal requirements. A good example may be seen in the FDA’s Module 1 requirements which may be found in the eCTD Technical Conformance Guide. This guide cites the following sections for Module 1 (some of which may not be included, depending on the specific type of submission):

1. FDA Regional eCTD Backbone Files
2. Cover Letter and Reviewers Guide
3. Cross References to Previously Submitted Information that is not in eCTD Format
4. Labeling – including history, content and label samples
5. Advertisements and Promotional Labeling Material
6. Marketing Annual Reports
7. Information Amendments – responses to information requests that do not fit under any heading in Module 2, 3, 4, or 5
8. Letters of Authorization – from the DMF holder
9. Field Copy Certification
10. Risk Evaluation and Mitigation Strategy (REMS)
11. Regenerative Medicine Advanced Therapy (RMAT) Designation

The Conformance Guide provides a practical example for the other modules, so we’ll look at it again in upcoming posts in this series.

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

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Text Copyright © 2019 Katrina Rogers

Follow the links below to read each part of the series.

Electronic Regulatory Submissions Part 1

Electronic Regulatory Submissions Part 2

Electronic Regulatory Submissions Part 3

Electronic Regulatory Submissions Part 4

Electronic Regulatory Submissions Part 5

Electronic Regulatory Submissions Part 6

Electronic Regulatory Submissions Part 8

Electronic Regulatory Submissions Part 9

Electronic Regulatory Submissions Part 10

Electronic Regulatory Submissions Part 11

Electronic Regulatory Submissions Part 12

Electronic Regulatory Submissions Part 13

Electronic Regulatory Submissions Part 14

Electronic Regulatory Submissions Part 15

Electronic Regulatory Submissions Part 16