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eCTD AU module 1 and regional information

Specification and guidance for use, V3.1

18 October 2017

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Preparing for your eCTD dossier

Please note: V3.0 of the specification is acceptable until 30 June 2018. This version (V3.1) becomes effective on 1 January 2018.

Obtaining the e-Identifier

You will need an e-Identifier before you submit your first regulatory activity in eCTD format.

To obtain an e-Identifier:

  • send an email to esubmissions@health.gov.au
  • include the following information in your email:
    • the applicant's name as listed in the eBS client database
    • name of the active ingredient (the AAN or proposed AANs) or subject of an eCTD sequence regarding a Master File
    • a description of the submission (application type, dosage form), if referring to a medicine
    • name and address of manufacturing site, if referring to a Master File.

The e-identifier is:

  • a combination of the letter 'e' and six digits. Example: e123456
  • valid throughout the entire lifecycle of a product unless split from a package as explained in Transferring sponsorship.

Preparing the eCTD cover letter

Include the following information in the cover letter in addition to the CTD requirements for the Cover Letter:

  • the e-Identifier, the sequence and related sequence in the subject line, consistent with the eCTD envelope
  • a description of the eSubmission:
    • type and number of electronic media
    • approximate submission size, and
    • any characteristics concerning the media that we might need to know
  • a description of the software used to check the files for viruses and a statement as to whether the submission is virus free
  • the regulatory and information technology points of contact for the submission
  • information about the validation including:
    • the validation tool and version used
    • any findings e.g. errors, warnings or possible missing documents as designated by the Document Matrix that would be expected for your specific sequence type
  • a paper copy of the Cover Letter should be included with the physical media containing the eCTD. This is only necessary until we develop an electronic portal.

You do not need to include a copy of the validation report; however an electronic copy needs to be provided if requested.

Validating the eCTD sequence

You must validate your sequence prior to submitting to us. The validation software that you use should be able to validate the AU Module 1 criteria. We also validate each eCTD sequence using the AU Validation Criteria.

There are three types of eCTD validation findings:

  • Error - Critical finding:
    • validation findings categorised as errors must be addressed
    • non-compliance will lead to rejection of the sequence
    • Refer to Sequences with errors or deficiencies for further information.
  • Warning - Best practice recommendations:
    • validation findings categorised as warnings should be addressed
    • we recommend warnings be eliminated whenever possible
    • repeated or excessive issues may result in a request from us for you to fix the sequence and resubmit it.
  • Information - Information collected about the data being submitted. This includes:
    • a list of omitted possible documents as defined in the Document Matrix that might be required in a sequence
    • information about unusual lifecycle operations
    • information about study tagging files submitted, etc.

Please minimise sequences with warnings and address any warnings in the Cover Letter.

You must validate your applications prior to submitting to the TGA. See the section in this document headed eCTD preparation tools for further comment on suitable publishing and validation tools.

Sequences with errors or deficiencies

We will not process sequences with validation errors. You will need to re-submit the sequence without validation errors. Evaluation will not proceed until a sequence free of validation errors and been provided. For further information or to discuss specific validation errors please contact esubmissions@health.gov.au.

If your sequence has content deficiencies, you will need to submit changes in a follow-up sequence as part of the application lifecycle.

Naming the eCTD dossier

Name the eCTD dossier after the e-Identifier and include the sequence number.

Example - e123456\0001

Selecting a media format

The size of a sequence is only limited by the size of your media format.

You may use the following media formats for an eCTD sequence to enable the eSubmission to be submitted as one unit:

  • Compact Disc-Recordable (CD-R) conforming to the Joliet specification
  • Digital Versatile Disc-Random Access Memory (DVD-RAM) Universal Disc Format (UDF) standard
  • Digital Versatile Disc-Recordable (DVD+R/-R) recorded in the Universal Disc Format (UDF) standard
  • Universal Serial Bus media (2.0 or higher)
  • Portable External Hard Drive (USB 2.0 or higher).

We do not return the media.

Do not use:

  • passwords
  • double-sided discs.

Sending your eCTD dossier

If your sequence is less than 100Mb and you have it ready by the time you complete the online pre-submission application form, you can upload it as a zip file directly into the form.

OR

If the file size is small enough to attach to an email, do so and email it to esubmissions@health.gov.au.

OTHERWISE

Follow the guidance in Part B of general Dossier requirements located at General dossier requirements: Part B: Electronic dossiers.

Feedback on validation

We will contact you if we have any issues during the validation and/or uploading an eCTD sequence.

Within the next 12 months, validation of your submission will be automated. Once that occurs the validation result will be sent to the email address(es) indicated in the Envelope. This will be an automated process and it is the responsibility of the contacts that you nominate to take any required action indicated in the response. It is therefore recommended that an alternative key contact be listed.

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