AU regional content
Please note: V1.0 of the specification is acceptable until 30 June 2018. This version (V2.0) becomes effective on 1 January 2018.
Regional content refers to the Australian specific information to be included within your NeeS application.
- Regulatory requirements and content for module 1 is described within CTD Module 1.
- The validation criteria to support the content is described within the NeeS Validation Criteria spreadsheet in the AU Validation Criteria 3.1 Excel workbook.
- Use the NeeS Sequence Matrix to determine what combination of sequence type and sequence description is relevant to your specific sequence.
Module 1 administrative and prescribing information
The ICH Common Technical Document (CTD) specifies that:
- Module 1 should contain region specific administrative and product information.
- Module 3.2.R should be used for any additional drug substance and/or drug product information specific to Australia.
Regional file formats
Module 1
| Section ID | Business Terminology | File Format |
|---|---|---|
| 1.0 | Correspondence | |
| 1.0.1 | Cover letter | |
| XML form | Excel - XML | |
| 1.0.2 | Lifecycle management tracking table | |
| 1.2 | Administrative Information | |
| 1.2.1 | Application forms | |
| Other |
Where possible, generate PDFs from an electronic source.
Signatures may be embedded as a graphic file in the PDF.
All PDF files, in any module, should be v1.4, v1.5, v1.6 or v1.7 except where a specific requirement for a later version is defined.
Modules 2 to 5
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
In addition to the file formats defined for Modules 2 to 5 in the ICH eCTD Specification (pdf,726kb), we will allow comma separated value (CSV) and plain text (TXT) files in Modules 4 and 5 to allow for specialist analysis, e.g. population pharmacokinetics analysis.
Electronic signatures
Whilst electronic signatures – for example, public key digital signatures – will be crucial, particularly for authentication of electronic submissions and documents, we are currently accepting:
- Digital signatures as an adjunct to written signatures.
- Scanned signatures where the documents make up part of the checksum of a NeeS submission.
Empty or missing sections
In applications for medicines:
- Provide detailed statements justifying the absence of data or specific CTD sections in the relevant Quality Overall Summary and/or Nonclinical/Clinical Overviews e.g. Module 2.3, 2.4, or 2.5.
- Include a statement in the cover letter on the absence of expected Module 1 content (based on information in the Australian regional specification and validation criteria 3.1).
Do Not:
- Use documents with no substantive content – for example, documents that contain words like "not applicable" - in the NeeS structure. This causes delays for evaluators who must open and assess documents with no substantive content.
- Provide a justification for content that is typically absent for applications for generic medicines.
Table of contents, bookmarks and hyperlinks
Tables of contents
A NeeS format dossier must contain tables of contents (TOC) in PDF format.
For small dossiers
You may have one TOC referring directly to all dossier documents especially when only one module beside Module 1 is included. Example: certain variations.
For larger dossiers
The main TOC must be linked to module TOCs which are then further linked to the documents in each module.
- Do not include hyperlinks in the module TOCs to the documents in other modules.
The file containing:
- the main, submission-level TOC must be named ctd-toc.pdf and be located in the four digit number named folder for the NeeS submission. This folder comes next to the root or top level folder (named using the e-Identifier).
- the module tables of contents are named m1-toc.pdf, m2-toc.pdf, m3-toc.pdf, m4-toc.pdf and m5-toc.pdf and are located in the corresponding top level module folders.
TOCs included at the document level must be located within the same file as the rest of the document.
All documents lodged in a NeeS format dossier must be referenced from a hyperlinked table of contents. Hyperlinks for a document should always be provided to the first page of the appropriate file.
Examples for tables of contents
The following examples of the Table of contents are for guidance and illustrative purposes only.
The bold text in column 3 indicates where hyperlinks to the individual documents should be added.
Parts of Table 3 are shaded yellow, italicised and include an asterisk*; this indicates changes that have been made between the NeeS versions 1.0 and 2.0.
| Module | Title | Hyperlink |
|---|---|---|
| Module 1 | Administrative and prescribing information for Australia | Module 1 |
| Module 2 | Common technical document summaries | Module 2 |
| Module 4 | Nonclinical study reports | Module 4 |
| Module 5 | Clinical study reports | Module 5 |
| Module 1 | Administrative and prescribing information for Australia | Reference |
|---|---|---|
| 1 | Correspondence | 1 |
| 1.0.1 | Cover letter NeeS envelope form* | 1.0.1 |
| 1.0.2 | Lifecycle management tracking table | 1.0.2 |
| 1.0.3 | Response to request for information | 1.0.3 |
| 1.2 | Administrative information | 1.2 |
| 1.2.1 | Application forms | 1.2.1 |
| 1.2.2 | Pre-submission details | 1.2.2 |
| 1.2.3 | Patent certification | 1.2.3 |
| 1.2.4 | Change in sponsor | 1.2.4 |
| 1.3 | Medicine information and labelling | 1.3 |
| 1.3.1 | Product information and package insert | 1.3.1 |
| 1.3.1.1 | Product information-clean | 1.3.1.1 |
| 1.3.1.2 | Product information-annotated | 1.3.1.2 |
| 1.3.1.3* | Product information-approved* | 1.3.1.3* |
| 1.3.1.4* | Package insert | 1.3.1.4* |
| 1.3.2 | Consumer medicines information | 1.3.2 |
| 1.3.2.1 | Consumer medicines information-clean | 1.3.2.1 |
| 1.3.2.2 | Consumer medicines information-annotated | 1.3.2.2 |
| 1.3.2.3* | Consumer medicines information - approved* | 1.3.2.3* |
| 1.3.3 | Label mock-ups and specimens | 1.3.3 |
| 1.3.3.1* | Label mock-ups and specimens - clean* | 1.3.3.1* |
| 1.3.3.2* | Label mock-ups and specimens - annotated* | 1.3.3.2* |
| 1.3.3.3* | Label mock-ups and specimens - approved* | 1.3.3.3* |
| 1.4 | Information about the experts | 1.4 |
| 1.4.1 | Quality | 1.4.1 |
| 1.4.2 | Nonclinical | 1.4.2 |
| 1.4.3 | Clinical | 1.4.3 |
| 1.5 | Specific requirements for different types of applications | 1.5 |
| 1.5.1 | Literature based submission documents | 1.5.1 |
| 1.5.2 | Designation applications - supporting documents* | 1.5.2 |
| 1.5.3 | Genetically modified organisms consents | 1.5.3 |
| 1.5.4 | Additional trade name declarations | 1.5.4 |
| 1.5.5 | Co-marketed medicine declarations | 1.5.5 |
| 1.5.6 | Combination medicine consent | 1.5.6 |
| 1.5.7 | OTC product assurances | 1.5.7 |
| 1.5.8 | Umbrella brand assessment | 1.5.8 |
| 1.6 | Master files and Certificates of Suitability | 1.6 |
| 1.6.1 | Relevant external sources | 1.6.1 |
| 1.6.2 | Applicants declaration | 1.6.2 |
| 1.6.3 | Letters of access | 1.6.3 |
| 1.7 | Compliance with meetings and pre-submission processes | 1.7 |
| 1.7.1 | Details of compliance with pre-submission meeting outcomes | 1.7.1 |
| 1.7.2 | Details of any additional data to be submitted | 1.7.2 |
| 1.7.3 | Declaration of compliance with pre-submission planning form and planning letter | 1.7.3 |
| 1.8 | Information relating to Pharmacovigilance | 1.8 |
| 1.8.1 | Pharmacovigilance systems | 1.8.1 |
| 1.8.2 | Risk management plan | 1.8.2 |
| 1.9 | Summary of biopharmaceutic studies | 1.9 |
| 1.9.1 | Summary of a bioavailability or bioequivalence study | 1.9.1 |
| 1.9.2 | Justification for not providing biopharmaceutic studies | 1.9.2 |
| 1.1 | Information relating to paediatrics | 1.1 |
| 1.11 | Foreign regulatory information | 1.11 |
| 1.11.1 | Foreign regulatory status | 1.11.1 |
| 1.11.2 | Foreign product information | 1.11.2 |
| 1.11.3 | Data similarities and differences | 1.11.3 |
| 1.11.4 | Foreign evaluation reports | 1.11.4 |
| 1.12 | Antibiotic resistance data | 1.12 |
| Module 2 | Common technical document summaries | Reference |
|---|---|---|
| 2.4 | Nonclinical overview | 2.4 |
| 2.5 | Clinical overview | 2.5 |
| 2.6 | Nonclinical written and tabulated summary | 2.6 |
| 2.7 | Clinical summary | 2.7 |
| Module 4 | Nonclinical study reports | Reference |
|---|---|---|
| 4.2 | Study reports | 4.2 |
| 4.2.1 | Pharmacology | 4.2.1 |
| 4.2.1.1 | Primary pharmacodynamics | 4.2.1.1 |
| Study report 1 | 4.2.1.1 | |
| Study report 2 | 4.2.1.1 | |
| Study report 3 | 4.2.1.1 | |
| 4.3 | Literature references | 4.3 |
| Reference 1 | 4.3 | |
| Reference 2 | 4.3 | |
| Reference 3 | 4.3 |
| Module 5 | Clinical study reports | References |
|---|---|---|
| 5.2 | Tabular listing of all clinical studies | 5.2 |
| 5.3 | Clinical study reports | 5.3 |
| 5.3.1 | Reports of biopharmaceutic studies | 5.3.1 |
| 5.3.1.1 | Bioavailability (BA) study reports | 5.3.1.1 |
| Study report 1 | 5.3.1.1 |
Bookmarks and hyperlinks
The navigation through a NeeS format dossier is based on:
- electronic tables of contents
- bookmarks
- hypertext links.
We can increase the efficiency in evaluating your application if you prepare the documents so we can quickly locate content.
We recommend you:
- Use bookmarks and/or Tables of Content to assist us with navigating through PDF documents to quickly find information.
- Include Table of Contents, and/or if appropriate, a Table of Tables, Table of Figures, etc. on the first page for documents with more than five pages and with multiple sections.
The following image describes the hierarchy for tables of contents and bookmarks.
Related information and guidance
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
- ICH eCTD Specification (pdf,726kb) - Appendix 7
Baseline submissions
A baseline submission is a resubmission of currently valid documents that you have already provided to us in a paper format. If transitioning from paper we advise that you move directly to eCTD rather than NeeS.
Cover letter for baseline submissions
When making a baseline submission, you need to include a statement about each of the following points in the covering letter:
- the format used for the previous dossier(s)
- when the previous dossier(s) was submitted
- verify that the formatting is the only change to the previous dossier(s) and there are no amendments to content
- all the information in the baseline submission was in the previous version(s) of the dossier
- any omissions in the baseline submission do not cause the content to be misleading.
Changing from paper to NeeS
When changing from paper to NeeS we recommend you:
- use a baseline sequence as a start of a NeeS application
- provide as much content as possible in the NeeS baseline sequence.
You can define the sections provided in a baseline sequence, but make sure that any omissions do not cause the content to be misleading.
We prefer the baseline submission to consist of high quality electronic source documents, but we will accept good quality scanned images with Optical Character Recognition (OCR) as this will help us search the text during the evaluation process.
We do not evaluate the baseline submissions and you do not need hyperlinks between documents.
Baseline sequence
Use the sequence type Baseline and sequence description Reformat in the lifecycle management table.
Initial baselines of paper submissions
The baseline should:
- normally be submitted as sequence 0000
- always be a separate sequence
- never include new regulatory activities.
The first new regulatory activity – for example, the next variation, in NeeS format should then be submitted as sequence 0001.
| Sequence | Sequence type | Sequence description | Related sequence |
|---|---|---|---|
| 0000 | Baseline | Reformat | 0000 |
| 0001 | C-Extension of Indication of COPD | Initial | 0001 |
| 0002 | Supplementary information | Response to Request for Information | 0001 |
| 0003 | H-Minor Variation | Initial | 0003 |
| 0004 | F-Major Variation - New Strength | Initial | 0004 |
Transferring sponsorship
If all products included under an e-Identifier are transferred to a new sponsor, the e-Identifier and the related sequences are transferred to the new sponsor.
Acquiring sponsor
The e-Identifier will transfer with the medicine, unless:
- there were multiple medicines submitted under the same e-Identifier
and
- you only acquired a portion of those in the transfer.
In the case of partial transfers, we will assign new e-Identifiers to the new sponsors.
Begin the first sequence of the new application with the next sequence number that would have been submitted under the old e-Identifier (see Table 1 below). This will indicate to evaluators that the medicine was initially reviewed under a different identifier.
Make sure you include the e-Identifier of the previous eCTD application in the cover letter of the new eCTD application.
Relinquishing
The future sequences of the medicines that remain under the initial identifier will continue as usual, however you should:
- remove the medicines you transferred from the envelope starting with the next sequence
- mention their removal in the cover letter.
| Sponsor FFF | Sponsor PPP | Sponsor YYY | Activity/Task |
|---|---|---|---|
| Product A Product B Product C Product D n000111 | |||
| 0001 | Application for Products A, B, C and D from Sponsor FFF | ||
| 0002 | A regulatory activity or notification | ||
| Product A Product B n000111 | Product C Product D n000222 | PPP submits first sequence as 0003 referencing the transfer from n000111 and submitting a regulatory activity. | |
| 0003 | |||
| 0003 | 0004 | Companies FFF and PPP undertake business as usual, using their own respective sequences. | |
| Product A Product B n000111 | Product C n000222 | Product D n000333 | YYY submits first sequence as 0005 referencing n000222. |
| 0005 | Companies FFF, PPP and YYY undertake business as usual. | ||
| 0004 | 0005 | 0006 |