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AU NeeS specification: Module 1 and regional information

30 June 2015

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AU regional content

Please note: This version (V1.0) of the specification is acceptable until 30 June 2018. Version 2.0 becomes effective on 1 January 2018.

Regional content

Module 1 administrative and prescribing information

The ICH Common Technical Document (CTD) specifies that:

  • Modules 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.

Use the eCTD Sequence Matrix spreadsheet in the AU Regional Specification and Validation Criteria 3.0 Excel workbook Australian eCTD regional specification and validation criteria 3.0 to determine the content that is relevant to your specific regulatory activity.

CTD Module 1 Administrative information and prescribing information for Australia is being updated for the new content and numbering of Modules 1 and 3.2R.

Regional file formats

Module 1

Table 2 - File formats that can be included in Module 1
Section ID Business Terminology File Format
1.0 Correspondence  
  1.0.1 Cover letter PDF
  1.0.2 Lifecycle management tracking table PDF
1.2 Administrative Information  
  1.2.1 Application forms PDF
Other   PDF

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 there is a specific requirement for a later version is defined.

Modules 2 to 5

How to access a pdf document

*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,725kb)*, 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 eCTD regional specification and validation criteria 3.0).

Do Not:

  • Use documents with no substantive content – for example, documents that contain words like 'not applicable' - in the NeeS structure. This creates 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 eSubmission 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.

Table 3 - Example: Main CTD table of contents
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
Table 4 - Example: Module 1 Table of contents
Module 1 Administrative and prescribing information for Australia Reference
1.0 Correspondence 1.0
1.0.1 Cover letter 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 Package insert 1.3.1.3
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
1.3.3 Label mock-ups and specimens 1.3.3
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 Orphan drug designation 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
1.10 Information relating to paediatrics 1.10
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
Table 5 - Example: Module 2 Table of contents
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
Table 6 - Example: Module 4 Table of contents
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
Table 7 - Example: Module 5 table of contents
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

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.

Table of contents contains hypertext links to modules, which in turn contains hypertext links to documents. Bookmarks are located throughout documents and refer back to modules and table of contents

How to access a pdf document

*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.

Baseline submissions

A baseline submission is a resubmission of currently valid documents that you have already provided to us in a paper format.

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[5] - for example, the next variation, in NeeS format should then be submitted as sequence[6] 0001.

Table 8 demonstrates the baseline as an initial NeeS sequence
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

Footnotes

  1. A subgroup of an Application which can be a group of related sequences for one approval or notification process. Usually defined for the lifecycle of the specific approval process.
  2. A package of information bundled together in an electronic structure providing information to the agency

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