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Brochure: Pre-submission phase: Type A and D applications

New chemical or biological entities, biosimilars or new generic medicines

29 June 2016

About the proposal

The pre-submission pilot will test the effectiveness of removing the need to provide a 'Module 2 or equivalent' with your Pre-submission Planning Form (PPF). It's anticipated that this will reduce the pre-submission workload for applicants and reduce the overall registration timeline by at least one month.

The pilot commenced on 1 February 2016 and has been extended until 30 September 2016.

Participation is optional and the current registration pathway will still be available.

The pilot changes aim to enhance the pre-submission phase of the existing prescription medicines registration pathway and are not intended to have any negative impact on applicants.

Participation in the pre-submission pilot

To be eligible you need to submit a

  • Type A application for a New Chemical or Biological Entity or Biosimilar or Type D application for a New Generic Medicine with
  • a validated Version 3.0 eCTD dossier

Proposed process

Diagram showing the proposed process

Submitting your dossier under the pilot

  1. Complete all sections of the current PPF (from TGA website).

    Ensure you have met the standard pre-PPF requirements in relation to:

    • orphan drug designation
    • literature based submissions, and
    • new proprietary and non-proprietary ingredient names.
  2. Notify your intent to partake in the pilot in Section 1.4.

    At the start of Section 1.4 of the PPF enter the phrase 'Please process this application in accordance with the pre-submission pilot'. Please enter 'by the end of [insert relevant month and year]' as the dossier lodgement date.

    Example of Section 1.4 completed in February 2016

    Diagram showing how the PPFs should be completed for lodging in February 2016
  3. Lodge your PPF by the fifteenth of the month (from February 2016) without 'Module 2 or equivalent'.
  4. Wait for the full submission number to be generated by electronic lodgement system (i.e. 'PM-yyyy-xxxxx-z-stream number').

    Contact if you experience any difficulties with this step.

    Be aware that there will be no 'Milestone 1' communication from the TGA for pilot applications. Evaluation Plans will be provided at Milestone 2, following which the standard business rules will apply.

  5. Submit your complete dossier via the usual procedure by the end of that same month.
    Proposed dates for 2016 pilot submissions
    PPF lodged before eCTD lodged before Milestone 2 Letter Due
    15 February 29 February 31 March
    15 March 31 March 30 April
    15 April 30 April 31 May
    15 May 31 May 30 June
    15 June 30 June 31 July
    15 July 31 July 31 August
    15 August 31 August 30 September
    15 September 30 September 31 October

    The next working day will apply when dates fall on weekends or public holidays.

    If you have any questions, please contact