eCTD submission

TGA Released Guidance On eCTD Baseline Submission

TGA updated guidance for the baseline submission for converting their dossier format from paper, Common Technical Document (CTD) or Non-eCTD electronic Submission (NeeS) to electronic Common Technical Document (eCTD).

The resubmission of currently valid documents already provided to the TGA in another format such as paper, CTD or NeeS is known as a baseline. This guidance provides information on how to compile and submit an eCTD baseline sequence.

TGA strongly recommend that you use a baseline as the start of your eCTD dossier when changing from paper, CTD or NeeS.

A strong baseline creates a solid foundation to develop a new eCTD lifecycle. It also provides an opportunity to resolve any issues with structure or format issues associated with the NeeS format.

Sponsors should submit an eCTD baseline if they are making significant changes to your dossier structure including:

  • combining two or more NeeS dossiers into one eCTD dossier
  • Splitting one NeeS dossier into multiple eCTD dossiers.

Baselines are not assessed; however, the content and layout can affect future applications.

Document requirements in a baseline sequence

A baseline must only contain currently valid and approved documents that you have previously provided to us.

We prefer that you submit a complete baseline consisting of a full module 1, 2, 3, 4 and 5. However, we recognise that this is not always practical.

At a minimum, include the:

  • cover letter
  • tracking table (if transitioning from NeeS you can include your NeeS tracking table history)
  • approved PI
  • approved CMI
  • approved labelling
  • information relating to pharmacovigilance (such as RMP)
  • Module 2, 3, 4 or 5 data that will be referenced in future applications.

The cover letter must:

  • clearly identify the sequence as an eCTD baseline sequence
  • list the products and ARTG numbers included in the baseline
  • provide details on the format used for the previous dossier, for example ‘transitioning from NeeS (n123456) to e123456’
  • provide assurances that:
    • all information included is a resubmission of currently valid documents and no new or unapproved information is included in the sequence
    • formatting is the only change to the previous dossier and there are no amendments to the content
    • any omissions in the baseline do not cause the content to be misleading.

TGA also provide format of baseline as follows:

  • use high-quality electronic source documents (if not available, we will accept good quality scanned images with Optical Character Recognition (OCR))
  • hyperlinks are not required.

Sequence submission information requirements

When providing the sequence:

  • include the Sequence Type: Baseline {seq-type-46}
  • include the Sequence Description: Reformat {seq-desc-25}
  • relate the baseline to itself
  • use the “therapeutic area prefix” as the submission number (for example ‘PM’ for prescription medicines)
  • do not provide any other applications within this sequence.

For More Information on Baseline Submission, kindly refer below link.

https://www.tga.gov.au/resource/ectd-baseline-sequences

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