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TGA presentation: ARCS webinar, 22 June 2018

Presentation: eCTD Module 1.3 - Best Practices

29 June 2018

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Presentation

  • Presented by: Emma Richards, Evaluation Management Section, Prescription Medicines Authorisation Branch, TGA
  • Presented at: Online webinar
  • Presentation date: 22 June 2018
  • Presentation summary: 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. For any further clarification please email .

Transcript

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

Slide 1 - Presentation overview

  • Module 1.3 Lifecycle Management Examples
  • Other Module 1.3 Considerations / Best Practice
  • Questions

Slide 2 - Reminder - Module 1.3

Table 8 Heading element 1.3 - Medicine information and labelling - highlighing new heading elements

Slide 3 - 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'.

Slide 4 - 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

Slide 5 - 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.

Slide 6 - 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

Slide 7 - 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.

Slide 8 - 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.

Slide 9 - 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.

Slide 10 - 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.

Slide 11 - Electronic submissions update

  • New Electronic submission hub at 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.

Slide 12 - Questions?

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