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. The TGA anticipates that these initiatives will incentivise the uptake of the eCTD format for submissions.

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