ARIM, ARIM Publisher, Australia, eCTD, RIM+

Australia Proposing Mandatory eCTD starting 2019

In late October 2018, Australia’s Therapeutic Goods Administration (TGA) opened consultation regarding their proposed schedule to make eCTD mandatory for prescription drug dossier submissions. The full proposal document can be found at the link above.

The Electronic Common Technical Document (eCTD) is the predominant format for sending documents for marketing and investigational applications or variations to health agencies worldwide. I really really shouldn’t have to tell you what it is at this point. The US FDA, European Medicines Agency (EMA), and Health Canada all require such submissions in eCTD format except in some of the less common circumstances, such as non-commercial investigational applications. Australia is proposing that they join that club.

TGA proposes that the mandate be phased in over the next two years, with new applications first, giving you a little more time to switch gears on variations and other changes.

Stage 1 – eCTD mandatory First Quarter 2019

  • New Chemical Entity (NCE)
  • New Biological Entity (NBE)
  • Biosimilar
  • New Combination Medicine

Stage 2 – eCTD mandatory 1 October 2019

  • Extension of Indications
  • Major Variation
  • New Generic Product
  • Changes to PI involving the evaluation of data

Stage 3 – eCTD mandatory 1 July 2020

  • Extension of Indications – Generic Product
  • Additional Trade Name
  • Category 3 – Variation involving only chemistry, quality control and manufacturing information
  • Minor Variations
  • S14 – Consent under S14 to waive compliance
  • Notifications
  • Master Files
  • Periodic Safety Update Reports (PSURs)

This should improve the quality of review, and also greatly improve efficiency of sponsor submissions. In May of 2018, about 56% of the submissions were eCTD, with only 10 failing validation.  The non-eCTD electronic submissions (NeeS for short) had more than 107 validation failures, or over 10 times as many in number, 13.4 times as a share of the submissions. Eliminating those validation errors would shave days or weeks off the approval time.

This schedule should not be difficult for companies to implement – the eCTD has been around for 15 years and there are plenty of vendors who can provide software or publishing services (but we have a favorite). If this will impact you, TGA is accepting comment on their proposal at the web site link above, through December 4. There is a standard comment form to download on the link above.

The best news is that TGA is not proposing any changes to their implementation of the eCTD: if you’re using an eCTD-based publishing system such as IQVIA RIM+ (formerly ARIM), just select eCTD as the submission Format Type. Otherwise, contact us for how we can set you up to use the IQVIA RIM+ system, or how IQVIA services can assist you in assembling your submissions in eCTD format for TGA or elsewhere in the world.

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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