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CTD Module 1

3 August 2020

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1.7 Compliance with meetings and pre-submission processes

Overview

This section of CTD Module 1 holds documents relating to pre-submission meetings held between the TGA and the applicant and identifies how any issues raised by the TGA in the Planning letter have been addressed in the dossier.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.7.1 Details of compliance with pre-submission meeting outcomes (if meeting held) mandatory mandatory mandatory mandatory
1.7.2 Details of any additional data to be submitted (if agreed) mandatory mandatory not required not required
1.7.3 Declaration of compliance with Pre-submission planning form and Planning letter mandatory mandatory not required not required

Module 1.7.1 Details of compliance with pre-submission meeting outcomes

When to include details of compliance with pre-submission meeting outcomes

Include when one or more scientific advice meetings and/or pre-submission meetings with the TGA have resulted in outcomes that the applicant must address to comply with application requirements. See also Pre-submission meetings with TGA.

How to prepare details of compliance with pre-submission meeting outcomes

Identify:

  • the date(s) of the meeting(s)
  • the outcomes arising from the meeting(s) requiring applicant action
  • how the outcomes from the meeting(s) have been addressed in the dossier
  • any agreements reached at the meeting.
Note:

Meetings include all relevant meetings requested by an applicant or TGA and include meetings conducted in any format (i.e. face to face, teleconference or videoconference). There may be multiple meetings before PPF or dossier lodgement.

Ensure the information provided in Module 1.7.1 is an accurate reflection of the meeting(s) and any outcomes that need to be addressed.

All meetings provide guidance only and outcomes are without prejudice and are not considered binding on the TGA.

Module 1.7.2 Details of any additional data to be submitted

In general, no additional data should be submitted during the course of the evaluation of an application under the standard prescription medicines registration process or Priority review registration process, other than relevant safety data and data specifically requested by the TGA.

When to include details of any additional data

Include details of additional data to be submitted when discussions have resulted in the TGA agreeing to accept additional data during the course of evaluation.

How to prepare information about any additional data

Include:

  • a copy of the TGA's agreement that additional data could be lodged
  • confirm the agreed date for lodgement
  • provide details of the additional data that TGA agreed to accept.
Note:

Additional data:

  • are to be submitted to the TGA by a date mutually agreed between the TGA and the applicant
  • must be well defined and relate to a particular and limited aspect of the application
  • are not intended to facilitate inadequate or premature applications. The acceptance of additional data is at the discretion of the TGA
  • may affect target timeframes.

Module 1.7.3 Declaration of compliance with Pre-submission planning form and Planning letter

When to include a declaration of compliance with Pre-submission planning form and Planning letter

Include when the application is one for which a Pre-submission planning form (PPF) was lodged with the TGA.

How to prepare a declaration of compliance with Pre-submission planning form and Planning letter

After reviewing the PPF, TGA's Planning letter and the dossier to be submitted, prepare a declaration that:

  • Describes how each issue identified in the TGA's Planning letter has been addressed.
  • States that the application is consistent with the PPF in both scope and scale; or
  • Describes all differences with appropriate justifications for their inclusion or exclusion in the dossier.

Information for applicants completing a pre-submission planning form

Important information on pre-submission and submission

The TGA will check the application for consistency with the PPF. Any differences between the information provided on the PPF and the resulting application may result in the TGA considering the application not effective. For example, the inclusion of an additional indication in the application at the submission phase increases the scope of the application and will not be accepted.

If an application will differ in scope and scale from that indicated in the PPF, contact the Application Entry Team before lodging the dossier at AET.Application.Entry.Team@health.gov.au.

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