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Prescription medicines: PPF only Pre-submission phase option

19 September 2016

The pre-submission pilot for prescription medicines will conclude at the end of September 2016 and continue as a business as usual pre-submission phase option for Type A and Type D eCTD submissions. The results from the online survey were taken into consideration and the TGA thanks those who responded.

Sponsors may choose to submit their Type A or D applications via the standard process or lodge a PPF unaccompanied by a draft Module 2 or equivalent in line with the process in place under the pilot. The preferred option should be indicated in the PPF in Section 1.4 by the inclusion of the text 'Please process this application in accordance with the PPF only pre-submission phase option'.

As of the 1 February 2017 the 'PPF only' pre-submission option will be available for all Category 1 prescription medicine application types. We anticipate that these initiatives will incentivise the uptake of the eCTD format for submissions.

Pre-submission pilot survey

28 June 2016

We are currently seeking feedback in relation to the pre-submission pilot initiative in order to inform future planning. We encourage you to participate in our online survey so that your opinion is heard with respect to the pre-submission phase of the registration process.

For all enquiries relating to the pilot please contact .

14 December 2015

The TGA is introducing pilot changes to the pre-submission phase of the prescription medicines registration process. Participation in the pilot will be possible for all Type A (New Chemical and New Biological Entities and Biosimilars) and Type D (New Generic Medicine) applications accompanied by a validated version 3.0 eCTD. The pilot commenced on 1 February 2016 and will run until 30 September 2016.

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 overall registration timeline by at least one month.

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