Implementation arrangements - Priority Review

Version 1.0

26 June 2017

Introduction and overview

As part of the Government response to the Review of Medicines and Medical Devices Regulation (MMDR review), the TGA is developing a Priority Review pathway for the registration of novel prescription medicines for Australian patients. The pathway is for faster assessment of medicines where there is substantial evidence demonstrating they provide a major advance in treatment of serious or life-threatening conditions, and there is a significant unmet clinical need. In Australia, there is currently no formal expedited route for approval of medicines.

The TGA is aiming to have the Priority Review pathway in place in July 2017.

A complete data dossier will be required to support Priority Review applications. Prior to lodgement of a Priority Review submission for registration, applicants will be required to seek Priority Review designation dependent on meeting all three of the following eligibility criteria:

  • the indication of the medicine (the priority indication that is the subject of the designation application) is for the treatment, prevention or diagnosis of a life-threatening or seriously debilitating condition; AND
  • no therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the Australian Register of Therapeutic Goods (ARTG); OR, if one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are included in the ARTG, there is substantial evidence demonstrating that the medicine provides a significant improvement in the efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods; AND
  • there is substantial evidence demonstrating that the medicine provides a major therapeutic advance

Consistent with commonly accepted good regulatory practice, the implementation of the new Priority Review pathway is proposed to occur in two stages. The implementation timeline has been developed to clearly communicate the details of the transition and describes the key milestones and associated implementation dates.

Key points in the timeline

This implementation plan specifically applies to Priority Review designation and registration applications. Guidance material is available on the TGA website to assist applicants in compiling and submitting designation applications. The TGA will monitor and report on the number of designation applications and decision outcomes on eligibility for priority designation and publish this information on the TGA website.

The key steps in the process captured for the transition and implementation phase are:

  • lodgement of the Priority Review designation application
  • lodgement of the Priority Review submission for registration

Implementation plan

Implementation plan

Milestone Description
A

You are strongly encouraged to notify us of your planned designation application at least one month prior to lodgement. Early notification will assist us with resource planning which contributes to the timely assessment of your designation application and submission for registration.

At this stage, TGA will commence accepting early notifications of the intent to lodge a Priority Review designation application as part of the implementation arrangements. Early notifications will be particularly important during the first stages of Priority review implementation.

B

The new Priority Review regulation comes into effect

TGA provides a new designation application e-form

TGA guidance on Priority Review published:

  • All three Priority Review criteria must be met for the Priority Review designation application to be eligible.
  • Applications are expected to be in the correct format and contain all relevant information as indicated in the guidance documents and must be lodged using the new designation application form.
  • The designation decision will be made within 20 working days.
  • Decision outcomes on eligible Priority Review designations will be published on the TGA website.
  • The validity of the Priority Review designation will lapse six months after the designation is granted.
C

TGA starts to accept Priority Review designation applications

Please note that the application can only be a priority OR a standard pathway application, not both

D First designation decisions possible under the Priority Review designation process
E Earliest opportunity to lodge Pre-submission Planning Form (PPF) with valid Priority Review designation with TGA
F TGA starts to accept submissions for registration with valid Priority Review designation for evaluation under the Priority Review registration pathway
G Ongoing monitoring of the number of submitted designation applications and decision outcomes and the time from designation application lodgement to decision
H The impact of changes will be reviewed in the short term considering designation application numbers, designation outcomes and stakeholder feedback. The guidance material will be reviewed and updated if required
I Medium-term review of the Priority Review pathway (to assess the program once designated medicines have had sufficient time to complete the registration process)