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AU eCTD specification: Module 1 and regional information

Version 3.0

14 April 2015

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Business protocol for preparing for your eCTD transaction

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

Obtaining the eSubmission identifier

eCTD submissions rely on the eSubmission Identifier to create the top level folder. This then forms the anchor for subsequent sequences and relative file referencing so that hyperlinks can refer to previously submitted documents. Applicants who have chosen the eCTD format must continue in the eCTD format for all future regulatory activities.

You will need an eSubmission identifier before you submit your first regulatory activity[4] for an application[5] in eCTD format.

To obtain an eSubmission identifier:

  • send an email to esubmissions@tga.gov.au
  • include the following information in your email:
    • the applicant's name as listed in the eBS client database
    • Name of medicine (the AAN[6] or proposed AANs) or subject of Master File
    • a description of the Application (application type, dosage form), if referring to a medicine
    • Name and address of manufacturing site, if referring to a Master File.

The identifier is:

  • made up of a letter and six digits. Example: e123456
  • valid throughout the entire lifecycle of a product unless split from a package as explained elsewhere.

eSubmission identifiers when transferring sponsorship

If all products included under an eSubmission Identifier are transferred to a new sponsor, the eSubmission Identifier and the related sequences[7] are transferred to the new sponsor.

Acquiring sponsor

The eSubmission Identifier will transfer with the medicine, unless:

  • there were multiple medicines submitted under the same eSubmission Identifier

and

  • you only acquired a portion of those in the transfer.

In the case the partial transfers, we will assign new eSubmission Identifiers to the new sponsors. Begin the first sequence of the new application with the next sequence number that would have been submitted under the old eSubmission Identifier (see Table 1). This will indicate to evaluators that the medicine was initially reviewed under a different identifier.

Make sure you include the eSubmission Identifier of the previous application in the cover letter of the new application.

Relinquishing sponsor

The further sequences of the medicines that remain under the initial Identifier will continue as usual, however you should:

  • remove the medicines you transferred from the envelope starting with the next sequence
  • mention their removal in the cover letter.
Table 1 eSubmission Identifiers and transfer of Sponsor activities/tasks
Sponsor
FFF
Sponsor
PPP
Sponsor
YYY
Activity/Task

Product A

Product B

Product C

Product D

e000111Text

0001 Application for Products A, B, C and D from Sponsor FFF
0002 A regulatory activity or notification

Product A

Product B

e000111

Product C

Product D

e000222

0003 PPP submits first sequence as 0003 referencing the transfer from e000111 and submitting a regulatory activity.
0003 0004 Companies FFF and PPP undertake business as usual

Product A

Product B

e000111

Product C

e000222

Product D

e000333

0005 YYY submits first sequence as 0005 referencing e000222
0004 0005 0006 Companies FFF, PPP and YYY undertake business as usual

Preparing the eCTD cover letter

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

  • the eSubmission 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 eSubmission 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[8]. 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

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.
  • 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 eSubmission Document Matrix that might be required in a sequence
    • information about unusual lifecycle operations
    • information about study tagging files submitted, etc.

Please minimise sequences[9] with warnings and address any warnings in the Cover Letter.

We recommend you use one of the validation tools on our website to validate your applications prior to submitting to us.

Sequences with errors or deficiencies

We will reject sequences with validation errors and you will need to re-submit unless you gain our agreement.

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

Related information and guidance

File: Australian eCTD Regional Specification and Validation Criteria.xls located at Electronic submissons - Validation.

Structuring the application folder

Use an application[5] folder named after the eSubmission identifier and include the sequence folder(s) as sub-folder(s) with their contents.

Example - D:\e123456\0001.

Selecting a media format

The size of an eSubmission is only limited by the size of your media format.

You may use the following media formats for an eCTD sequence regulatory activity 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 application

Pack the cover letter and media securely prior to sending.

For Australia Post

Send to our postal address:

Electronic Submissions
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606 Australia

You can request proof of delivery from Australia Post for packages sent by Express Post.

For courier services

Send to our site address:

Electronic Submissions
Therapeutic Goods Administration
136 Narrabundah Lane
Symonston ACT 2609 Australia

Your submission package is traceable by the courier company throughout transport and delivery, and you can request proof of delivery from your courier.

Feedback on validation of application

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


Footnotes

  1. The term Regulatory Activity is a subgroup of an Application which can be a group of related sequences for one approval or notification process - for example, one variation. One Regulatory Activity is usually defined for the lifecycle of the specific approval process.
  2. The term Application in relation to TGA's medicine registration process and is the top group of a series of sequences for the same product - for example, active ingredient. One Application is usually defined for the complete life cycle of the specific product.
  3. Australian Approved Name
  4. A package of information bundled together in an electronic structure providing information to the agency
  5. electronic Common Technical Document
  6. A package of information bundled together in an electronic structure providing information to the agency

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