Anavex Life Sciences Corp (AVXL)

[sokol]

Fast Track Approval Pathways in Australia. Here is an internet search and AIChat inquiry about early approval of a drug in Australia. It may be Anavex has its best chance for approval of Anavex 2-73 in Australia. Also, according to AIChat, no surrogate biomarker is necessary for early approval in Australia. See this:


# Fast track approval pathways

Last updated

16 March 2023

Before a new prescription medicine can be available for use in Australia, the TGA assesses it for safety, quality and efficacy.

There are three pathways the TGA can use to assess a prescription medicine: the standard pathway, the priority review pathway and the provisional approval pathway.

Priority review and provisional approval are pathways that fast track prescription medicines onto the market, making them available to patients sooner than they would be under the standard pathway.

Typically, a pharmaceutical company needs many years to collect evidence that confirms the safety, quality and efficacy of a medicine by running clinical trials and doing other research. It could also take up to eleven months for us to review this evidence through the standard pathway depending on the complexity of the medicine. In the meantime, some patients with serious, life-threatening conditions could need urgent access to the medicine, but not be able to access the medicine until it is approved.

For this reason, medicines for serious or life-threatening conditions are sometimes eligible to undergo a fast track process to make the medicine available to patients sooner than normal. The sponsor must apply and the medicine must meet criteria to use a fast track pathway. For example, the medicine must be a major advance over any similar medicines that are already approved for supply.

Fast track pathways can be used for both new medicines and new uses for already approved medicines.

Some medicines that have already been approved through a fast track pathway treat conditions like prostate cancer, skin cancer, and haemophilia.

On this page: [Priority review](https://www.tga.gov.au/fast-track-approval-pathways#priority) | [Provisional approval](https://www.tga.gov.au/fast-track-approval-pathways#provisional) | [It is important to report side effects](https://www.tga.gov.au/fast-track-approval-pathways#report) | [Other important information](https://www.tga.gov.au/fast-track-approval-pathways#other) | [Medicines subsidies through the PBS](https://www.tga.gov.au/fast-track-approval-pathways#pbs)

## Priority review

Under priority review we aim to finish our review of a medicine up to three months earlier.

We can complete these reviews faster because the approval process is more flexible. For example, under priority review we ask the pharmaceutical company questions about their application as they arise, rather than sending the questions as a group after we finish a round of assessment.

Priority review involves the same amount and type of evidence as the standard review process, and so has no impact on the level of safety, quality or efficacy of the medicine. Unlike provisional medicines, a medicine approved under priority review will receive ongoing approval, identical to approval under the standard pathway.

The flexible approach we take on priority applications is much more resource intensive than the standard pathway. This is not a feasible option for all medicines, so the pathway is reserved only for medicines that treat serious and life-threatening conditions.

## Provisional approval

We can give provisional approval to medicines which provide a promising treatment for a serious or life threatening condition. This makes the medicine available for a limited period while the pharmaceutical company completes final clinical trials.

Under the standard pathway, a medicine is not available until after all clinical trials have been completed, so this can make a medicine available up to two years earlier than normal.

In order to do this, the sponsor must apply and we must be satisfied that the benefit of earlier access for patients is greater than the risk of not yet having all of the supporting evidence that we usually require.

For further information, please refer to the [Provisional approval pathway: prescription medicines](https://www.tga.gov.au/provisional-approval-pathway-prescription-medicines) webpage.

## It is important to report side effects

While all medicines may have side effects, it is particularly important that you report to your doctor any issues you experience with a provisionally approved medicine.

Any issues should also be reported to us so we can build up the full picture of a new medicine's safety profile. You can ask your doctor to do that on your behalf.

One of the best ways to report is over the phone to an NPS Medicinewise pharmacist on [1300 134 237](tel:[phone]) as they can ask questions to get the best information and provide advice on how to manage the side effect. You can also [report any issues](https://www.tga.gov.au/node/287456) directly to the TGA.

## Other important information

Your doctor will give you information about medicines they prescribe, including if the medicine is provisionally approved. However, for more information you can also check the [Consumer Medicines Information (CMI)](https://www.tga.gov.au/node/287207).

When looking at the CMI for provisional or priority medicines, you may notice a [black triangle symbol](https://www.tga.gov.au/node/287699) (). This symbol is a reminder to report side effects. The black triangle does not mean that there are known problems with the medicine, only that the medicine is new, or being used in a new way, and the TGA is seeking as much information as possible to get the full picture of its safety profile.

If you have concerns about any medicine you are taking, always consult your doctor.

## Medicines subsidies through the PBS

Subsidies are determined and administered by a different section of the Department. For information on which medicines are subsidised by the Australian Government, consult the [Pharmaceutical Benefits Scheme website- external site](http://www.pbs.gov.au/pbs/home;jsessionid=1939lc3p78hu1lbb47c3u9zdy).

https://www.tga.gov.au/fast-track-approval-pathways

I asked AIChat if a surrogate biomarker was required for early approval of a drug in Australia. This is the response I received from AIChat:

No, the use of surrogate biomarkers is not specifically required for fast track approval of drugs in Australia. Australia does not have a formal Fast Track program similar to the FDA's Accelerated Approval Program in the United States. However, there are several routes available in Australia for expedited approvals of innovative drugs that target serious or life-threatening conditions.

In Australia, the provisional approval pathway is the closest analogue to the accelerated or conditional approval pathways in other jurisdictions. The TGA, which is responsible for drug approvals in Australia, grants provisional approval to drugs that demonstrate promise in treating serious or life-threatening medical conditions where no or only limited treatment options exist.

To qualify for provisional approval, the drug must show promise over the defined target indication, and its net clinical benefit profile is expected to outweigh its potential significant risks. Like other regulatory frameworks conditional approval, the provisional approval captures data before confirming sufficient confirmatory data comes forward through post-marketing clinical trials requested of the approval gain. This allows reinforced assessment of the drug performance against that observed with the surrogate endpoint and against placebo or established standards of care with adequate statistical analysis.

However, even without a formal Fast Track pathway, it is possible for companies to request an accelerated review or expedited assessment by the TGA. The TGA can grant these requests if they are satisfied that the drug meets the requirements for priority assessment and has the potential to provide high clinical benefits to a high need patient population for life threatening or serious diseases when treatment options cannot address the necessary clinical need.

While surrogate markers can offer a useful surrogate of depending on the context of benefit surrogates within the intended population, their use is subject to assessment against the common consensus of proofs established and practical outcomes in individual cases. Their deployment can depend on the clinical target endpoints, intended population, and other factors at the time of their use in clinical trials on which their value as a surrogate is dependent until confirmed.