TGA Mandates eCTD V3.1 Module 1 Specification & Section-wise Updates

Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region. Therapeutic Goods Administration (TGA) of Australia has rolled out a new mandate to use latest version 3.1 Module 1 Specification for Regulatory submissions post June 30th, 2018.

TGA has initiated accepting submissions adhering to version 3.1 from the day it has come to effect in action i.e., Jan 1st, 2018. And at the same time, the agency has also provided transition time to align with the latest version. Submissions made, based on both versions (3.0 & 3.1) will be accepted until the deadline which is on June 30th, 2018, after which it will be deemed a mandate to adhere to the latest version (3.1). Moving forward, any submission which will be submitted to the agency need to be in Version 3.1, with all the changes mentioned by Regulatory Authority.

In this latest version, TGA has incorporated changes to existing XML directory structure and content files and made some additions which make it more accessible for reviewing and recollecting data.

What’s in the Updated Version?

The update includes specific sections marked as “updated” and “newly added” to clearly outline the difference. As per the Agency’s guidance Section-wise updates include:

New sections included

  • 1.3.1.3 Product information - approved
  • 1.3.2.3 Consumer medicine information 

Updated sections

  • 1.3.1.4 Package insert
  • 1.3.3.1 Label mock-ups and specimens – clean
  • 1.3.3.2 Label mock-ups and specimens – annotated
  • 1.3.3.3 Label mock-ups and specimens – approved

New Sequence Types

  • Notification
  • CN
  • Extension of provisional registration
  • Duplicate: Requirement inclusion for potential work sharing options.
  • Provisional registration – TGA initiated variation: Support MMDR recommendation implementation

Updated Sequence Types

  • Product Withdrawal

Advantages of Updated Version:

The updated version allows implementation of Medicine and Medical Device Review (MMDR)’s recommendations; including the priority, provisions and notification pathways. Further, the update also allows to support request for multiple changes in eCTD dossier. Providing greater user clarity, it also enhances the dossier quality.

The detailed nature of changes/additions must be interpreted from a Regulatory perspective which will need expertise in understanding the submissions in eCTD format. With minimal time left for transition, it is of utmost importance to achieve compliance in line with the latest version and to partner with a proven Regulatory submissions expert for effective tracking and streamlining the submission.

Freyr’s eCTD submission solutions:

  • Easy migration from paper/NeeS to eCTD
  • Templates for eCTD documents
  • Latest Module 1 Specification for TGA
  • Migrating from older Module 1 specification to Latest Module 1 specification
  • Dedicated team for gap analysis
  • Quick turnaround of eCTD dossier
  • Well experienced eCTD publishers for Global Regulatory requirements.

Keeping abreast with global agency updates, Freyr simultaneously upgrades Freyr SUBMIT – an eCTD publishing and submission tool – to suit the immediate client requirements. Considering the TGA eCTD V3.1 update, Freyr SUBMIT is already upgraded with v3.1 Module 1 Specification template and successfully dispatched the same to the existing clients to support their submissions to TGA.

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