Draft process flow of expedited pathway: reproduced from the TGA Presentation ‘Prescription Medicines MMDR Reforms Overview and Designation Process: Expedited Pathways for Prescription Medicines’, 14 October 2016 

 

One of the outcomes of the ‘Review of Medicines and Medical Devices (MMDR Review)’ is the adoption of expedited pathways for approval of prescription medicines in Australia.

The TGA proposes to adopt two expedited pathways for the registration of prescription medicines:

  • Priority Review which will involve review of a complete dossier in a reduced timeframe and is scheduled for implementation in the next 12 months. The timeframe for registration is aiming for 150 working days.
  • Provisional Approval in which early data on safety and efficacy will enable registration for a limited period (2-3 years) whilst additional clinical data in generated; provisional approval would be granted in the absence of full Phase III clinical data. Post-market monitoring and surveillance would be conducted by both the Sponsor and TGA to proactively manage safety and efficacy. A full nonclinical data package will be a requirement for a provisional approval. This type of expedited review is scheduled for implementation by the TGA in the next 18 months.

 

In order to fulfil the requirements for expedited review the medicine must meet all three criteria:

  1. Serious medical condition (life threatening or seriously debilitating medical condition) and
  2. Unmet medical need and
  3. Major therapeutic advantage: For a Priority Review it is necessary to demonstrate a substantial improvement in safety and/or efficacy. For a Provisional Approval it is required to show promising evidence of a substantial improvement in safety and/or efficacy as compared to the currently registered medicines for the same disease/condition.

 

Overall the introduction of expedited review should provide a positive outcome for Australian patients’ who will have earlier access to new medicines without compromising quality, safety or efficacy.