This section of Module 1 holds the cover sheet, the Cover letter, the Lifecycle management tracking table, and the applicant's response to request/s for information (answers to questions) from TGA.
Summary of requirements
|Section||Description||Category 1/COR report-based||Variations to quality only (e.g. Category 3)|
|New registration||Variation||New registration||Variation|
|1.0.2||Lifecycle management tracking table||mandatory||mandatory||mandatory||mandatory|
|1.0.3||Response to request for information (if questions raised)||mandatory||mandatory||mandatory||mandatory|
Module 1.0.1 Cover letter
When to include the Cover letter
Include in Module 1.0.1 for all regulatory activities and for each sequence associated with that regulatory activity.
How to prepare the Cover letter
Prepare the letter on company letterhead and sign by an authorised officer of the company.
The Cover letter should not contain any evaluable information. Do not include responses to questions raised by TGA in the Cover letter, since they have been assigned a specific location in Module 1.0.3.
Include the signed Cover letter in Module 1.0.1.
Ensure the letter contains the following information:
Initial cover letter
Include the following information in the initial Cover letter for a regulatory activity:
- a description of the submission, including appropriate regulatory information
- the submission number allocated at the time of:
- lodging the Pre-submission planning form (category 1/COR report-based applications) or
- submitting a variation using the variations e-form (other variations to quality).
- regulatory activity category and regulatory activity type(s)
- the trade name(s), active ingredient name(s), dosage forms and strengths of the medicine(s)
- the AUST R numbers of the existing registered medicines for applications seeking to vary those medicines
- the identity of any studies supplied in the dossier that have been previously evaluated by the TGA, including information relating to the initial lodgement of the data (submission ID and date).
All Cover letters
Include the following information in the Cover letter for all sequences:
- the eIdentifier in the subject line
- the full name, phone number and email address for:
- the regulatory point of contact
- information technology points of contact
- a description of the electronic dossier provided for that sequence, including type and number of electronic media, approximate submission size, and if appropriate, characteristics relating to the media
- a statement that the electronic dossier is virus free with a description of the software used to check the files for viruses
- an indication of which validation tool and version was used as well as a statement addressing any issues found in the accompanying validation report.
Note to evaluators
A Note to evaluators is not a requirement, but sponsors occasionally include them to provide further information to facilitate navigation (e.g. on hyperlinking) etc. To promote a consistent approach to naming them and placing them within the regulatory activity, a Note to evaluators should be filed as a leaf element under the m1-0-1-cover heading. The title of the leaf should be "Note to evaluator".
Module 1.0.2 Lifecycle management tracking table
When to include the lifecycle management tracking table
The Lifecycle management tracking table will support transparency and ease tracking of sequences regardless of the format.
The sequence number is a four digit number referring to a package of information bundled together in an electronic structure for eCTD submissions to TGA. Sequence numbers, as defined for eCTD submissions, are not applicable for non-eCTD electronic submissions (NeeS) format dossiers; however, the use of a four digit number in the top level folder name is recommended.
The initial application should normally have a sequence number of 0000. As additional data are submitted, for example, in response to questions, the sequence number will advance, 0001, 0002, etc.
An updated Lifecycle management tracking table should be placed in Module 1.0.2 any time a new sequence is submitted.
How to prepare a lifecycle management tracking table
Prepare a table listing sequences submitted to the TGA. An example is shown below.
|Sequence||Sequence Type||Sequence Description||Related Sequence|
|0001||C-Extension of Indication of COPD||Initial||0001|
|0002||Supplementary information||Response to Request for Information||0001|
|0003||H-Minor Variation, Not Resulting in a New Register Entry||Initial||0003|
|0004||F-Major Variation - New Strength||Initial||0004|
Module 1.0.3 Response to request for information
When to include a response to a request for information
Include information in this section only when providing a response to a request for information from the TGA.
Do not include this document in the dossier:
- when the submission is initially lodged
- to provide details on how the applicant has addressed any items raised by the TGA in the Planning letter. Information on the applicant's actions to address issues raised in the Planning letter must be provided at Module 1.7.1 Details of compliance with pre-submission outcomes.
How to prepare a response to a request for information
- Assess the TGA's request for information and determine whether it will be necessary to provide revised or new CTD documents as part of the response
- Prepare a Cover letter (see Module 1.0.1)
- Prepare a document that includes an appropriate response to each question in the TGA's request (see 'Appropriate response' below) and include in Module 1.0.3.
Including new documents that belong elsewhere in the CTD
- Place new documents submitted as part of the responses to questions in the appropriate part of the CTD (elsewhere in Module 1 or in Modules 2-5).
- Include a reference/hyperlink to the location of these new documents with the answer to the question in Module 1.0.3.
For example, if the answer requires a revised version of the Product Information:
- include any comments with the answer in Module 1.0.3
- include copies of the new version of the Product Information in Module 18.104.22.168 (clean copy) and Module 22.214.171.124 (annotated copy).
Appropriate response to a request for information
An appropriate response to a request for information is one that:
- provides a comprehensive response that addresses all aspects of the question(s)
- may need to include updates, or addenda, to the relevant summaries and/or overview sections of Module 2 when a response includes extensive data/documents and/or analyses.
In an eCTD dossier, provide hyperlinks to references previously submitted in the eCTD format.
When referencing CTD documents that were provided previously to the TGA as part of a hard copy dossier or NeeS dossier, include detailed references to CTD documents:
- the submission ID
- the module
- tab identifier
- page number
For example: See PM-2012-12345-6-7, Module 3, 3.2.P.4.3 Method validation, p 23.
It is highly recommended but not mandatory to use a baseline when converting to eCTD from another format. It provides the essential information in just one sequence to create an eCTD format product life cycle. The baseline is a resubmission of currently valid documents that you have already provided to us in another format. Further guidance can be found in the eCTD AU module 1 and regional information specification and guidance.