Today the TGA formally released the update AU Module 1 specifications for both eCTD and NeeS. The updated specifications will be available for use from 1 January 2018 and will cater for MMDR innovations, specifically Priority Review and Provisional Approval pathways. The existing specifications will be acceptable for use until 30 June 2018.
An electronic Submission (or eSubmission) is a set of registration files submitted in electronic form for the registration, or a variation to the registration, of a medicine. It is a set of files (Portable Document Format (.pdf), Microsoft Word files (.doc) or Rich Text Format (.rtf) and picture files like jpeg etc.) submitted in folders according to the current CTD format.
An electronic Common Technical Document (eCTD) is the electronic submission of registration files that are organised according to the ICH eCTD specifications (version 3.2.2) and the current version of the AU Module 1 specifications.
Other structures or formats may also be accepted, such as a Non eCTD electronic Submission (NeeS).
Australian eCTD submissions
The electronic Common Technical Document (eCTD) is a specification for the pharmaceutical industry to submit electronic applications to enter registered medicines into the Australian Register of Therapeutic Goods (ARTG) and is organised according to current Australian and ICH eCTD specifications.
- AU eCTD specification: Module 1 and regional information v3.0 - acceptable until 30 June 2018
- eCTD AU module 1 and regional information V3.1 - effective from 1 January 2018
The current ICH eCTD specification is ICH eCTD Specification V3.2.2.
The eCTD is the submission of (mostly) PDF leaf documents, stored in the eCTD directory structure, accessed through the XML backbone (index.xml) and with the files integrity guaranteed by the MD5 Checksum.
- Australian eCTD submissions: Frequently asked questions
- ICH electronic Common Technical Document (eCTD)
- ICH Specification v3.2.2 (Module 2-5)
- ICH eCTD Specification and Related Files (Look for the Change Control Process (Microsoft Word document) in the Change Control paragraph)
Non eCTD electronic Submission (NeeS)
The NeeS format should be considered as a transition stage towards the eCTD format.
A NeeS differs from an eCTD in that it does not contain an XML backbone or the quantity of MD5 checksum values as defined by the ICH - it is in essence, a collection of electronic files organised in folders.
However the NeeS module 1 version 2.0 does introduce an Excel form that is to be used to create an XML envelope. Also a NeeS version of the XML Sequence matrix with associated MD5 checksum value.
- AU NeeS specification: Module 1 and regional information - acceptable until 30 June 2018
- AU NeeS specification: Module 1 and regional information, V2.0 - effective from 1 January 2018