Electronic submissions
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.
The current Australian eCTD specification is AU eCTD specification: Module 1 and regional information v3.0.
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 file downloads
The eCTD XML schema and related files are available below and allow the possibility of automated access by eCTD publishing tools.
- Australian regional backbone schema for module 1 (xsd,12kb)
- Style sheet for Australian regional backbone (xsl,28kb)
- W3C schema for XLink1.1 (xsd,10kb)
- W3C schema for XML namespace (xsd,6kb)
- Style sheet for the code files (xsl,3kb)
- Codes and defined lists for Regulatory Activity Lead (xml,1kb)
- Codes and defined lists for Sequence Description (xml,4kb)
- Codes and defined lists for the Sequence Type (xml,6kb)
The TGA has made available a sample eCTD submission with three sequences:
Checksum values
The MD5 checksum values of the files published by the TGA are listed below:
- xml.xsd: 382b0a4f7529d2c5f7b0af0aa713b0a5
- xlink.xsd: 52d1a3b8596e4fb61d3ec1cde24be16a
- au-regional.xsd [0.9]: e6549cb8f267623f864430249068564c
- au-regional.xsd [3.0]: 25300b93cf16674c3e4c0153345322fa
The MD5 checksum values for the ICH files can be found on ESTRI website.
Useful links
- 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)
Other structures or formats may also be accepted. A Non eCTD electronic Submission (NeeS) differs from an eCTD in that it does not contain an XML backbone or MD5 checksum as defined by the ICH - it is a collection of electronic files organised in folders.
A NeeS differs from an eCTD in that it does not contain an XML backbone or MD5 checksum as defined by the ICH - it is a collection of electronic files organised in folders.