How will you cope with the burden of eCTD submissions?
PharmOut dialed in to listen to the eCTD Introductory Meeting on July the 3rd, which was hosted by the TGA in Canberra and was run by John Bell, eCTD Project Manager, TGA and Kent Briggs, Lead Consultant, eCTD Implementation, from LORENZ Life Science. Kent referred to a lot of information already publically available on the TGA website and discussed work carried out on the eCTD project to date as well as key milestone dates for the pilot scheme.
It was highlighted that inconsistencies are expected from the eCTD pilot program. The process will be updated with assistance from industry feedback as the pilot progresses. From a legal perspective, the TGA will require submissions to be made on paper until legislation is changed.
A number of sections within the eCTD will be aligned with European and US submissions, and moving to the electronic format will remove the need for Annexes in Module 1. A number of the components of Module 1 have also been removed and included on the application form instead.
The TGA will accept the use of node extensions, study tagging files, file reuse and style sheets which are not accepted in some regions. The node extensions and study tagging files will need to be managed as they cannot be changed over the life cycle of the dossier. Reuse of files not only facilitates cross referencing within an application, but also between applications to the TGA if the structure of the application is known.
While the benefits of the eCTD are definitely attractive, the software required to validate, review and publish electronic applications for the entry of registered medicines on to the Australian Register of Therapeutic Goods (ARTG) is extensive and expensive. The pilot program focuses on submissions for prescription products where the CTD format is mandatory. However, the CTD format is now encouraged for all medicine categories. The TGA software testing may also include submissions across prescription, complementary, OTC products and master files with a view to extending the eCTD across all.
How will the smaller businesses in these industries cope with the burden of eCTD submissions – high software costs and expertise required to achieve an eCTD submission?
For further nformation on Australian eCTD submissions visit the TGA website
Good news that the TGA is moving forward with eCTD. This should simplify lodging applications in Australia especially for overseas companies who have previously submitted in the US and/or EU.