Specifications for Non-eCTD electronic Submissions (NeeS) v2.0.1

Module 1 

Submit the XML envelope in Excel or XML. Submit everything else in PDF format.

Modules 2 - 5 

See International Conference on Harmonisation's (ICH) document ICH M2 EWG Electronic Common Technical Document Specification

In addition to the file formats defined in this document, we allow comma separated value (CSV) and plain text (TXT) files in Modules 4 and 5. This allows for specialist analysis (e.g. population pharmacokinetics analysis).

Use the NeeS format to respond to questions and anything related to your dossier. This ensures all information relating to product evaluation is included in its dossier.

The structure of a NeeS format dossier must conform to the:

• Annex to the ICH guideline Organisation of the Common Technical Document for the Registration of Pharmaceuticals for human use - M4
• requirements set out in CTD Module 1 - Administrative information and prescribing information for Australia.

Module 1

The dossier must also contain region-specific administrative and product information in Module 1.

Module 3.2.R

Provide any additional drug substance and/or drug product information specific to Australia in Module 3.2.R.

Lifecycle tracking table

For every NeeS format submission, place an updated “tracking.pdf” in Module 1.0.2. This ensures transparency and simplifies sequence tracking.

Missing sections

Justify any missing data or common technical document (CTD) sections in the Quality Overall Summary or Nonclinical/Clinical Overviews.

Skip justifications for content typically absent in generic medicine applications.

Include a statement in the cover letter about any missing expected Module 1 content per Australian specifications and validation criteria 3.1. Avoid using documents with no substantive content, like those stating, “not applicable".

Table of contents (TOC)

A NeeS format dossier must include a TOC in PDF format.

• For small dossiers (1 module plus Module 1), include 1 TOC for all documents.
• For larger dossiers, include a main TOC linking to module TOC. Name the main TOC file “ctd-toc.pdf” and place it in the four-digit sequence folder.
• Name module TOCs “mx-toc.pdf” (x = module number) and place them in the corresponding module folders.

Ensure all documents are referenced from a hyperlinked TOC, linking to the first page of each file.

Bookmarks and hyperlinks

You should use of bookmarks and TOCs to assist us in navigating through PDF documents to quickly find information and evaluate your application.
 

You should include a table of contents (or a table of figures if appropriate) on the first page of documents with more than five pages.

Naming folders

Name the root folder of the dossier with the e-Identifier of the medicine followed by the subfolder name (sequence number) of 4 digits. For example: n123456\0001

The initial submission of a NeeS dossier should have a sequence number of 0000. As additional data is submitted, the next sequential number should be used.

For Module 1, read M1 NeeS File-Folder Names for recommended folder names.

For Modules 2 - 5, follow the ICH eCTD folder naming conventions as specified in Appendix 3 of the ICH eCTD specification.

Naming files

For Module 1, Read M1 NeeS File-Folder Names for recommended file names.

Follow ICH document ICH M2 EWG Electronic Common Technical Document Specification file naming conventions.

• For multiple files in one section with one recommended name, use the filename–var.pdf format (e.g., pharmaceutical–development–container.pdf), avoiding dashes or illegal characters.
• Folder/file paths must not exceed 180 characters, starting from the first digit of the four-digit folder name containing ctd-toc.pdf.
• Single folder/file names must be 64 characters or fewer, including the extension.

The NeeS envelope form is a downloadable Microsoft Excel worksheet you can use to create your XML envelope.

Fill in the red-highlighted fields on the left side of the form to ensure the XML envelope is complete.

Select options from the dropdown menus for regulatory activity lead, sequence type, and sequence description. Refer to the hyperlinked titles for more information.

For sequence types and descriptions with free text fields, additional value fields will appear once selected.

To add extra fields (e.g., additional approved names), insert rows and copy the first row’s contents into each new row.

After completing the form:

• Copy the yellow-shaded ‘envelope.xml’ preview.
• Paste it into a new Notepad document.
• Save the file as ‘envelope.xml’.

Include this file in the ‘1001-cover’ subfolder of your NeeS application and reference it in the m1-toc.pdf.

Follow eCTD guidance for submitting withdrawal and baseline sequences, and transferring sponsorship in NeeS:

• Compile an electronic Common Technical Document (eCTD) baseline sequence
• Withdraw information from your electronic Common Technical Document (eCTD) submission
• Transfer ownership of your electronic (Common Technical Document) eCTD dossier.

For help submitting a sequence, email eSubmissions@health.gov.au.

For help with eCTD specifications, email EDR@health.gov.au.