The TGA have just approved the first medicine via the provisional approval pathway (17th July, 2019) for Pembrolizumab (KEYTRUDA).
This is a major milestone and will, no doubt, encourage other companies to consider filing this way in Australia.
What is Australia’s ‘Provisional Approval Pathway’?
As part of the Government’s response to the Review of Medicines and Medical Devices Regulation (MMDR review), the TGA are implementing a pathway for the provisional registration of prescription medicines.
Approval through the provisional pathway will be on the basis of preliminary clinical data where there is the potential for a substantial benefit to Australian patients.– Australian Government, Department of Health, Therapeutic Goods Administration
The provisional pathway allows sponsors to apply for time-limited provisional registration on the Australia Register of Therapeutic Goods (ARTG).
This provides early access to a new medicine or indication where the inherent benefit is greater than the risk of not having a full data package with Phase 3 clinical data.
What are the benefits?
- Time to Market – Prescription medicines on the market 2 years earlier.
- Reuse regulatory documentation – Increased alignment with other overseas regulators that provide similar pathways.
- Less cap raising – Helps offset development costs by deferring some or all of Phase 3 clinical until after product sales begin.
What are the eligibility criteria?
- New prescription medicine or new indication
- For treating a serious condition
- Favourable comparison against existing therapeutic goods
- Major therapeutic advance
- Evidence of a plan to submit comprehensive clinical data.
Provisional approvals are limited to a maximum of six years. Registration will automatically lapse after that time, unless a full application is submitted.
Sponsors can apply for full registration of their medicine at any time, with a full data package including pivotal Phase 3 data.
Before lodging an application to provisionally register a medicine, it is advisable to have a TGA meeting first, followed by the “Determination Process”.
What is the registration process?
The steps in the overall process are outlined below.
Figure 1: Provisional Approval Pathway in Australia
If you would like further information, guidance or assistance on the provisional approval pathway please contact us for a confidential discussion.