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Replies to post #257660 on Anavex Life Sciences Corp (AVXL)
The provisional approval pathway, in contrast to
the priority review pathway, enables a time-limited
registration of a promising drug, based on preliminary
(usually phase II) clinical data.3
If approved, the
drug will be available for two years and the drug’s
sponsor can apply for extensions up to a total of
six years. Typically, the final stages of clinical trials
(phase III) that address the safety, quality and
efficacy of a medicine can take several years. By
accepting applications for assessment before these
trials are completed, a medicine could be brought
to market potentially years sooner than under
previous processes.
Up to July 2019, 13 applications had been determined
as eligible for the provisional approval pathway. The
first approval using this pathway was for an extension
of indications for pembrolizumab.
The TGA only grants provisional approval if the
potential benefit of early availability outweighs the
risks of incomplete data about the drug. For example,
a drug may be potentially life-saving, but if trial data
on morbidity or mortality are not available, or the
results are based on surrogate end points that have
not been shown to reliably predict clinical benefit, it
may not be eligible for this pathway
What are the benefits of the provisional approval pathway?
Prescription medicines that provide a major therapeutic advance for Australians could come to the market up to two years sooner than in the current framework.
The pathway provides a formal and transparent mechanism for expediting registration of promising new medicines with preliminary clinical data for sponsors and TGA business areas.
Increased alignment with other overseas regulators that provide similar pathways.
Applications for provisional approval
Sponsors are strongly encouraged to organise a pre-submission meeting with the TGA to discuss planned applications for provisional determination.
For more information on the application process, see our guidance for sponsors on the provisional approval determination process, provisional registration process, and post market requirements, extensions, and transition to full registration process.
The implementation plan for provisional approval provides more information on how we will implement the pathway. It outlines the timeframes for acceptance of the first determination applications and submissions for provisional registration under the provisional approval pathway.
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