prescription medicine registration process

Hi All

Since the April announcement re the market authorisation application for ArTiMist and the 255 days approval period I have been doing  research in what's involved with this process. The TGA have a great document on their site titled "Prescription medicine registration process. Version 2.1, September 2014."

The document lists and details the 8 Milestone steps involved and time frame related to each step. Pages 41 to 45 simplifies the steps and can recommend the read. There is even an Appendix 1 that sets out sample timeline and dates which I reproduce below with current dates.

Milestone 1. Pre-submission. Complete
Milestone 2 Submission the ArTiMist dossier has been lodged.. Notification letter received advising that the application has been ACCEPTED. Complete.

April 3rd SUD Announcement. Assumed that the TGA issued their notification letter in late March 2017.

Milestone 3. Commencement of evaluation starts 1st April 2017. First round assessment phase.
Consolidation section 31 request sent from TGA to SUDA on or before 31st July 2017. ( A consolidated  Section 31  request for information is prepared.This includes requests from all evaluation units. This request is compiled in the final month of this phase and sent to SUDA on the date specified in the Planning letter.)

Milestone 4. Consolidated section 31 request period. There is a 30day option period for generic drugs and 60 day for new drugs. This is the only opportunity that applicants have to review the first round assessment reports for factual content.
Assuming 30day option this will end 31st Aug 2017. ( if the wait for the submission has been worth the wait there should be only a few Section 31 questions to answer, we hope, which should speed up the process.)

Milestone 5. Second round assessment phase ( assuming 30 day response period)
Review of section 31 queries.
Period ends 30th September 2017

Milestone 6. Expert Advisory Review Phase.(NOT required for a generic)

Milestone 7. Decision made by the delegate.
Applicant advised of decision mid November 2017

Milestone 8. Post-decision phase.
ARTG entry created on/before mid December 2017

This follows on quite nicely from the great The Great Auk post.

The whole TGA document is a worthwhile read on a wet day in NQ.

Enjoy.

kippax