29 June 2016 - 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. It's anticipated that this will reduce the pre-submission workload for applicants and reduce overall registration timeline by at least one month.

View TGA article