This presentation gives an overview of the expectations and best practices for structuring and formatting data in module 1.3 for submissions in the eCTD format using the Australian specifications version 3.1.

1. eCTD Module 1.3 – Best Practices
Emma Richards
Evaluation Management Section
Prescription Medicines Authorisation Branch, TGA
ARCS Electronic Submission Discussion Forum (ESDF) Meeting
22 June 2018

2. Presentation Overview
• Module 1.3 Lifecycle Management Examples
• Other Module 1.3 Considerations / Best Practice
• Questions
eCTD Module 1.3 – Best Practices 1

3. Reminder - Module 1.3
• Version 3.1 Module 1.3 layout.
• New heading elements
highlighted in yellow.
• See eCTD AU module 1 and
regional information V3.1 on the
TGA website for further
information.
eCTD Module 1.3 – Best Practices 2

4. Module 1.3 Lifecycle – Initial PI, CMI and Labels
• Initial sequence:
– clean copies of the draft PI, CMI and labels within m1-3-1-1-pi-clean, m1-3-2-1-
cmi-clean and m-1-3-3-1-mockup-clean using ‘new’.
• Response to request for information sequence:
– amended clean copies using ‘replace’.
– annotated copies of the draft PI, CMI and labels within m1-3-1-2-pi-annotated,
m1-3-2-2-cmi-annotated and m-1-3-3-2-mockup-annotated using ‘new’.
• Following negotiations:
– amended clean and annotated copies using ‘replace’.
– ensure ALL amendments are included.
• Following Approval:
– ‘approved’ copies of the PI, CMI and labels within m1-3-1-3-pi-approved, m1-3-2-
3-cmi-approved and m-1-3-3-3-mockup-approved using ‘new’.
eCTD Module 1.3 – Best Practices 3

5. Further information on the ‘Approved’ folder
• Should contain:
– current Australian ‘approved’ versions of PI, CMI and labels.
• Within eCTD:
– provide the ‘approved’ versions as a post-approval closing sequence.
 sequence type Supplementary Information
 sequence description Product Information
eCTD Module 1.3 – Best Practices 4

6. Module 1.3 Lifecycle Example - Changing the PI
• Initial sequence of next submission:
– clean copies of the draft PI within m1-3-1-1-pi-clean using ‘replace’.
– annotated copies of the draft PI within m1-3-1-2-pi-annotated using
‘replace’.
• No ‘approved’ PI is required as it was provided as part of the previous post-
approval sequence.
eCTD Module 1.3 – Best Practices 5

7. Module 1.3 Lifecycle Example - Concurrent change to the PI
• Initial sequence of second submission:
– clean copies of the draft PI within m1-3-1-1-pi-clean using ‘new’.
– annotated copies of the draft PI within m1-3-1-2-pi-annotated using
‘new’.
 annotated version to include changes requested as part of this
submission only.
• Note that the operation ‘new’ will result in a validation warning:
– justify validation warning within cover letter
– indicate there are concurrent submissions
– quote submission numbers
eCTD Module 1.3 – Best Practices 6

8. Module 1.3 Lifecycle Example - Concurrent change to the PI
• Following Approval of 1st PI change:
– clean copies of the ‘approved’ PI within m1-3-1-3-pi-approved using
‘replace’.
• Following Approval of 2nd PI change:
– clean copies of the ‘approved’ PI within m1-3-1-3-pi-approved using
‘replace’.
The ‘approved’ folder allows the TGA to track what changes have been finalized
this is important when there are multiple changes within multiple submissions.
eCTD Module 1.3 – Best Practices 7

9. Module 1.3 Lifecycle Example – Next change
• Initial sequence next submission:
– clean copies of the draft PI, CMI and labels within m1-3-1-1-pi-clean,
m1-3-2-1-cmi-clean and m-1-3-3-1-mockup-clean using ‘replace’.
– annotated copies also provided using ‘replace’.
• Recommend deletion of the other clean and annotated documents:
– ‘delete’ will result in validation warning.
– justify this validation warning within the cover letter.
To
eCTD Module 1.3 – Best Practices 8

10. Considerations for Notifications
• If a PI, CMI and/or label change is allowable as part of a Notification:
– submit the ‘approved’ documents as part of the initial Notification
sequence.
– ensure clean and annotated documents are also included.
Understanding Module 1.3 9

11. Considerations for transitioning from Module 1.3.3
• When using the updated regional specifications (Version 3.1), include labels
within 1.3.3.1-mockup-clean, m1.3.3.2-mockup-annotated and m1.3.3.3-
mockup-approved.
• Within Version 3.0 of the regional specifications labels were included within
1.3.3-mockup.
• Deletion of the labels from 1.3.3-mockup will result in an validation error.
eCTD Module 1.3 – Best Practices 10

12. Electronic Submissions Update
• New Electronic submission hub at https://www.tga.gov.au/electronic-submissions-
and-data-review.
• Update to the eCTD Document Matrix file download.
• Automation of validation of sequences.
• Transition period for the current regional specifications ends 30 June 2018.
eCTD Module 1.3 – Best Practices 11

13. 12
QUESTIONS?
eCTD Module 1.3 – Best Practices