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V1.0 of the specification is acceptable until 30 June 2018. This version (V2.0) becomes effective on 1 January 2018.
Introduction
This guidance:
- needs to be used in conjunction with the General dossier requirements
- provides general information on producing an electronic copy of a dossier in the NeeS format
- relates to preparing and structuring the data to be submitted in an electronic format to support applications to:
- register a medicine under Section 23 of the Therapeutic Goods Act 1989 (the Act)
- vary the registration of a medicine Section 9D of the Act.
The NeeS specification is an interim arrangement as applicants plan the move to full eCTD.
Summary of updates in version 2.0
Purpose of the updates
- Support the implementation of applicable parts of the Medicine and Medical Device Review (MMDR) recommendations; namely the notification pathway.
- Allow for the possibility of dossiers supporting requests for multiple changes (see further references in Appendix 1 of this document to 'Work sharing' and/or 'work grouping').
- Provide greater clarity to users.
- Enhance dossier quality (introduce additional validation criteria to assist with dossier quality).
- Allow for automation of some process steps within the TGA.
Summary of NeeS updates
The following documents and specifications have been updated as part of the upgrade to version 2.0:
- AU NeeS specification: Module 1 and regional information (this document)
- Australian regional specification and validation criteria (AU Validation Criteria v3.1.xlsx) and related files
For a comprehensive understanding of the updates introduced in version 2.0 refer to this document and to the Australian validation criteria where all updates (both new and changes) have been highlighted in yellow, italicised with an asterisk*.
Introduction of the NeeS envelope form
An envelope form has been introduced for NeeS submissions to allow greater validation of these submissions and the automation of the uploading processes.
The envelope form stores information within an 'XML envelope like' structure which allows the NeeS sequences to behave in a similar manner to eCTD sequences with XML backbones.
Automation will enable increased efficiencies and improve communication and information on submissions received and processed.
The information contained in the envelope is also linked to many validation criteria. This increases transparency of content and format required to improve the evaluation. It also helps to avoid delays due to missing content for a regulatory activity, or due to qualitative issues with the files provided.
To facilitate the creating of such 'envelope information', the TGA has provided an Excel form which will auto create the required content if filled in correctly. A detailed description of this form and how to complete it forms part of this document.
NeeS continues to be an interim option. The XML form will allow greater usability and control for NeeS submissions; however, sponsors are encouraged to transition to eCTD to obtain the benefits of lifecycle management and access to a greater variety of evaluation pathways.
For further information on any of the updates contact esubmissions@health.gov.au.
Module 1 Section updates
| New sections | Rationale |
|---|---|
| 1.3.1.3 Product Information - approved | The inclusion of an approved folder clearly distinguishes the approved copy from the working copies |
| 1.3.2.3 Consumer Medicine Information - approved |
| Updated sections | Previous | Rationale |
|---|---|---|
| 1.3.1.4 Package insert | 1.3.1.3 Package insert | Moved section ID to accommodate Product Information – approved |
| 1.3.3.1 Label mock-ups and specimens – clean | 1.3.3 Label mock-ups and specimens | Section has been divided to clearly distinguish the clean, annotated and newly added approved copies. |
| 1.3.3.2 Label mock-ups and specimens – annotated | ||
| 1.3.3.3 Label mock-ups and specimens – approved |
Sequence Type updates
| New | Rationale |
|---|---|
| Notification | To make available, Notifications for both Prescription Medicines and for OTC Medicines |
| CN | |
| Duplicate | Requirement inclusion for potential work sharing options. |
Where known, additional document requirements have been included within the Document Matrix for each of these new sequence types. As more detail on document requirements becomes available, we will update the Document Matrix that appears on the TGA website.
Separate specifications have not been developed for NeeS and therefore the sequence types and description updates are the same for NeeS as for eCTD.
However that not all registration pathways and therefore sequence types are available to dossiers submitted in NeeS. For further information contact streamlinedsubmission@health.gov.au.
| Updated Sequence Type | Previous | Rationale |
|---|---|---|
| Product Withdrawal | Withdrawal | Name change to better align with the use of this sequence type. Validation criteria have also been amended. |
NeeS validation criteria
Updates to the validation criteria for NeeS have been included within version 2.0.
New validation criteria have been included primarily to support the introduction of the NeeS Envelope, as well as new Sections and Sequence Types. Updates have also been made to some current criteria to provide further clarity based on experience gained to date.
Terminology
It is acknowledged that the terminology to describe regulatory activities and electronic submissions differs between regions. To assist users interpret this guidance and specification a brief list of terms used is described below.
| Term | Definition |
|---|---|
| Dossier | a structured set of folders/documents containing the information that supports your request for an evaluation by the TGA |
| eCTD | electronic Common Technical Document - an electronic standard for the Common Technical Document (CTD) providing the means for transferring information from pharmaceutical companies to agencies |
| *eCTD application | for the purpose of this document - refers to a collection of electronic documents filed under an e-Identifier and comprises of a number of sequences and regulatory activities |
| Envelope | Contains the metadata relevant to the eCTD or NeeS sequence. Metadata are referred to as envelope elements |
| e-Identifier | is a combination of a letter and six digits, for example in NeeS the format, n123456. It is the unique identifier for the NeeS application that tracks the products for the entire lifecycle (previously eSubmission Identifier) |
| leaf | Structural element of an eCTD submission delivering a document. It provides the link information to the document along with the title associated with the linked content. |
| NeeS | Non-eCTD Electronic Submission - an alternative electronic standard to eCTD consisting of PDF Files and PDF Table of Contents linking all content for navigational purposes |
| regulatory activity | a collection of sequences covering a specific request. Referred to in Australia as a submission e.g. Submission for a new chemical entity (NCE). |
| sequence | a sequence is a package of information bundled together in an electronic structure providing information to the agency. The contents of a sequence will depend on the regulatory activity type and whether it is the initial sequence of the regulatory activity or a follow-up providing additional data or changes. |
| Stream | An indication of the clinical team that will deal with a request to register a new product. Each stream corresponds to a therapeutic category. These are available on the TGA website. |
*Within Australia the words 'submission' and 'application' have very specific meanings within our regulatory framework and legislation. To avoid confusion 'eCTD application' will be used to describe eCTD related terminology as used by the ICH rather than 'application'.
Implementation/transition plan
To allow for planning and software updates we have incorporated a transition period for the uptake of the new version of the AU NeeS Module 1 specification.
The initial version of this specification was not given a version number. This updated version is given the number 2.0 to avoid confusion with the current NeeS version.
Timelines for implementation of version 2.0
- The AU NeeS Module 1 version 2.0 specification will be effective starting 1 January 2018.
- The AU NeeS Module 1 version 1.0 specification will be accepted until 30 June 2018.
Between 1 January 2018 and 30 June 2018, we will accept both the new version 2.0 and the current version 1.0 of the specification.