In a recent development, the Therapeutic Goods Administration (TGA), Australia has updated its guidance document titled “eCTD AU Module 1 & Regional Information,” making crucial changes to Module 1 v3.1 while adopting the International Council for Harmonization’s (ICH) electronic Common Technical Document (eCTD) v4.0 specification. This update significantly impacts sponsors and manufacturers, particularly those dealing with prescription medicines and their eCTD submissions.

An Overview of Version 3.1 Updates

This comprehensive update encompasses various eCTD documents and specifications, including AU eCTD specification Module 1, Australian eCTD regional specifications, validation criteria, XML schemas, related files, checksum values, and AU 3.1 eCTD sample submissions.

Rationale Behind the Updates

The updated guidance serves multiple purposes, aligning with recommendations from the Medicine and Medical Device Review (MMDR), supporting work-sharing, providing clearer instructions to users, enhancing dossier quality through additional validation criteria, and enabling automation of certain TGA processes.

Request a Consultation with Our Regulatory Experts

Consult Today

Key eCTD Updates

Module 1 Section Enhancements

• Introduction of new sections, such as “Product information – approved” and “Consumer medicine information – approved,” aimed to differentiate approved copies from the working ones.
• Updates to existing sections, like “Package insert” and “Label mock-ups and specimens,” for greater clarity.

Sequence Type Modifications

• Addition of the following new sequence types:
  • “Provisional registration – TGA initiated variation, notification, CN, and extension of provisional registration” to support the recommendations from MMDR.
  • “Duplicate” to support requirement inclusion for potential work-sharing options.
• Introduction of “Provisional approval – rolling data submission” to align with the implementation of MMDR’s recommendations.
• Inclusion of additional document requirements within the document matrix for each of these new sequence types.
• Changes in the nomenclature of existing sequence types, like “Product withdrawal,” for better alignment with the new sequence types; also, the amendment of validation criteria.

XML Element Additions

New XML elements within the AU envelope have been included to enhance capacity and facilitate future automation of the validation process.

eCTD Validation Criteria

The validation criteria for eCTD have been updated in version 3.1, which includes the addition of certain criteria to support the introduction of new XML elements. Moreover, some of the current criteria have been adjusted to enhance clarity based on accumulated experience.

Anticipated Updates – Module 1 v3.2

TGA is collaborating with industry partners to reform the existing “eCTD AU Module 1 and Regional Information”. This initiative is aimed at ensuring that regional requirements are aligned with current business needs. The update to Module 1 v3.2 is intended to enhance dossier quality and improve user clarity by:

• Amending defined lists and matrices to align with current business processes and allow flexibility for future adaptation.
• Reviewing the Australian eCTD validation criteria to provide clear and consistent requirements.
• Amending eCTD AU Module 1 heading elements to ensure descriptive, accurate, and comprehensive representation.

An updated technical specification and guidance for use (Module 1 v3.2) is set to be available online in February 2024.

Implementation Timeline for Module 1 v3.2

As published by the TGA on their official website (as of Feb 08, 2024), provided below is a well-defined timeline outlining the stages, from consultation with industry partners to mandatory adoption of Module 1 v3.2 in Q1 2025, ensuring a smooth transition for stakeholders.

Table 1: Timelines for Mandatory Adoption of Module 1 v3.2

Manufacturers and sponsors must stay informed about the updates in Module 1 v3.1 and prepare for the forthcoming changes. Stay tuned for more updates and leverage innovative solutions like Freyr SUBMIT PRO for eCTD submissions. Reach out to Freyr for further information on eCTD submission requirements in Australia.