ACUTA, ARCS, ARIM, Australia, eCTD, NeES

E-Submissions Looking Up Down Under

Australia’s Therapeutic Goods Administration (TGA) released updated guidance for both eCTD (electronic Common Technical Document) and NeES (Non-eCTD Electronic Submissions). Version 3.1 of the Australian regional eCTD specifications, and version 2.0 of the NeES specifications will be accepted starting January 1, 2018, and will be mandatory July 1, 2018.

Because the eCTD and NeES are both talking about the same kinds of submissions, and the same documents required, this means that the rules and validation criteria, are nearly identical. There are some changes to terminology, namely that the “eSubmission identifier” is now called an “e-Identifier” (a clue that they’re likely to use similar technology for non-submission communications), and the “applicant” is now called “client”, and the client ID is obtained from Australia’s eBS (eBusiness Services) website. A contact email is also required – which will be used to communicate automated validation information once that is put into production.

And if you’re scratching your head as to where those sorts of things go in the NeES format, which normally is just a bunch of linked PDF files, you’re in for a surprise: TGA will require an “Envelope XML Form” in NeES submissions, which contains much of the same metadata used in the eCTD. They provide a Microsoft Office Excel spreadsheet to build the form, which generates the XML automatically. One has to note that with the additional envelope XML requirements, if you are using a system such as ARIM to manage your submission assembly, there is very little reason not to use eCTD instead of NeES.

Other changes include:

  • New heading numbers for approved versions of the Package Insert and Consumer Medicine Information (sections 1.3.1.3 and 1.3.2.3)
  • Package Insert is shifted to 1.3.1.4 because of the above change
  • New heading numbers under Label Mock-Ups (section 1.3.3) for Clean, Annotated and Approved versions (1.3.3.1 is the Clean version, etc.)
  • The description and folder name for section 1.5.2 has changed
  • New sequence types for Notifications and CNs, and Withdrawal is now explicitly Product Withdrawal
  • The system has elements in place for worksharing and work grouping, but there are as yet no instructions as to how these will be used

New validation criteria include a ban on web- or email-based links and bookmarks within documents; files can now be up to 200MB in size; and a requirement that all documents over 10 pages have bookmarks, except for literature references and on the application forms and NeES table of contents.

ACUTA plans to support the Australian formats with a release of ARIM before the new versions take effect. Please contact us for information on how we can assist you with submissions to Australia and the rest of the world, with either ARIM submission software or our ARCS services.

Author: Joel Finkle

Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our clinical study reports to WordPerfect format for the FDA reviewer?" and he didn't say, "No." Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

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