At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for enhancing evaluation workflows and encouraged industry to make the transition to eCTD.
The TGA have published an updated eCTD AU module 1 and regional information specification and guidance for use (version 3.1).
The updated specification will be effective from 1 January 2018 and become mandatory from 30 June 2018. A number of new features have been incorporated into the AU specifications to support the Medicine and Medical Device Review (MMDR) recommendations, facilitate document lifecycle management and enhance the overall quality of dossiers.
The key features introduced into the updated specification include:
- New sequence types to cater for provisional registrations and future post-approval notifications
- Inclusion of new subfolders within Module 1.3 Medicine Information and Labelling to distinguish “approved” documents and facilitate appropriate life cycle management through the use of the “replace” operation.
- Additional validation criteria and updated best practice guidance regarding the use of bookmarks and hyperlinks, which now raises:
- Documents that contain bookmarks and hyperlinks with web or email destinations as a “warning”
- Documents longer than 10 pages which do not contain bookmarks as “Information”
- Updates to the eCTD envelope to facilitate future automation of TGA validation of dossiers
- Structural changes to the eCTD envelope to allow the future possibility for multiple changes for a single product (“work grouping”) or the same changes for multiple products (“work sharing”)
An updated AU NeeS specification and guidance for use version 2.0 has also been published and follows the same implementation timelines as the updated eCTD specification.
The key new requirement for applications in NeeS format is the introduction of a “NeeS envelope form” to assist the manual creation of an envelope.xml file. This NeeS envelope file is similar to the eCTD envelope and contains background information, such as the sponsor and application type, for each sequence/application. While completion of this form appears user friendly and not particularly onerous, this additional requirement provides further incentive for Sponsors to transition to eCTD!
To discuss how Commercial Eyes can assist you with all your eCTD and NeeS needs call our Regulatory Services team on +61 3 9251 0777.