The TGA, Australia is consulting on a proposed priority pathway for assessment of certain novel and life-saving biologicals.
Who is the consultation for?
The consultation is for consumers, healthcare professionals and the industry.
What is the purpose of the consultation?
The purpose of the consultation is to provide an opportunity for consumers, healthcare professionals and the industry to provide advice to the government on a Priority Review pathway for biologicals.
Specifically, it is to consult on:
- whether they support introduction of such a pathway
- eligibility criteria for the Priority Review pathway for biologicals
- the Process for determining whether a biological application meets the eligibility criteria for Priority Review (the ‘Determination Process’).
What are the objectives for the proposed Priority Review pathway for biologicals?
The objectives of the proposed Priority Review pathway are to:
- assist in achieving a faster assessment and earlier access to certain novel and life-saving biologicals that address unmet clinical needs for Australian consumers, bringing these to market faster than using standard evaluation pathways
- provide timely and flexible registration processes for sponsors seeking access to the Australian market for new and novel uses of biologicals that offer substantial benefits to Australian consumers increase alignment with other overseas regulators that offer accelerated assessment processes
- increase alignment with other overseas regulators that offer accelerated assessment processes.
The Priority Review pathway will prioritise the evaluation of novel biologicals that meet the
eligibility criteria and have a full dossier, with a view to reducing the target timeframe for a
decision regarding inclusion of the biological in the ARTG. A legislated timeframe of 150
working days is proposed for Priority Review, which is consistent with benchmarks set by
the EMA and the US FDA for similar programs, and the Priority Review pathway for prescription
medicines used by TGA.
What could be the eligibility criteria for a Priority Review pathway for biologicals?
While there are no standard criteria for priority pathways for biologicals, there are some
common considerations, namely the:
- seriousness of the disease or condition and its impact on people’s daily lives
- existence of effective interventions
- extent of (potential) innovation offered by the product, that is, whether the treatment provide a substantial benefit in some aspect of the patient outcomes.
Although the criteria are principles-based, fulfilling them will require an analysis of data
What are the proposed criteria for the acceptance of an application for Priority Review determination?
The eligibility criteria for Priority Review determination are designed to ensure that only
biologicals providing the most benefit to patients are eligible.
Priority Review:
- is based on a full dossier of data.
- is intended for biologicals that represent a major advantage over existing treatments available to Australian patients.
There are four criteria proposed for the Priority Review pathway for biologicals.
All these criteria must be satisfied for a biological to be eligible for Priority Review. A delegate of the Secretary, in practice a senior medical officer of the TGA, will determine the validity of the justifications against the eligibility criteria on a case-by-case basis. As part of the routine
determination process, the extent to which criteria are met will be assessed at the time a
decision is made on the application.
The four criteria are:
Criterion 1: New biological or new use – The biological is either a new biological or an already registered biological with a new use.
Criterion 2: Life-threatening disease or seriously debilitating condition – The biological is to be used for the treatment, prevention or diagnosis of a life-threatening disease or seriously debilitating condition.
Criterion 3: Fulfils an unmet clinical need or clinically significant improvement over already approved therapeutic goods – Either:
- No therapeutic goods that are intended to treat, prevent or diagnose the condition are entered on or included in the ARTG; or
- If one or more therapeutic goods that are intended to treat, prevent or diagnose the condition are entered on or included in the ARTG—there is substantial evidence demonstrating that the biological provides a clinically significant improvement in the safety or efficacy of the treatment, prevention or diagnosis of the condition compared to those goods.
Criterion 4: Major therapeutic advantage – There is substantial evidence demonstrating that the biological provides a major therapeutic advantage in patient outcomes when compared to existing treatments as defined by a magnitude well beyond the minimum threshold of clinical significance
Decision on the determination of eligibility for Priorty Review
Within TGA, the relevant delegate of the Secretary will assess the information provided by the
sponsor against the criteria to decide whether a biological should be granted a determination for the Priority Review pathway. It is proposed that the delegate will have a target timeframe of
20 working days from acceptance and acknowledgement to the sponsor of a complete application to make the decision.
There is more details available on all of the above in the consultation paper.
To which classes of biologicals is it proposed to apply the Priority Review pathway?
The Priority Review pathway is proposed to apply for biologicals that are either:
- Class 4: high risk
- Class 3: medium risk
- Class 2: low risk
It is proposed that the following biologicals will not be able to apply for Priority Review:
- Class 1: low risk and have an appropriate level of external governance and clinical oversight.
Classification is generally determined by the level of processing applied to the biological
(method of preparation, including whether minimally manipulated, the intended use of the
product, and the level of external governance and clinical oversight.
An example of a Class 1 product is a faecal microbiota transplant (FMT) product that is
manufactured within a hospital setting.
What are the expected benefits of a Priorty Review Pathway for biologicals?
It is envisaged that this pathway would allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time, where the assessment results in a decision by the TGA to include the biological in the Australian Register of
Therapeutic Goods (ARTG).
With industry poised to deliver more late-stage clinical and commercial biologicals for such illnesses with high unmet medical need, bringing such products to patients through optimised regulatory and expedited pathways is crucial.
Where can you find out more about the consultation?
You can find out more about the consultation in the consultation paper.
How can you repond to the consultation?
You can respond to the consualtion via the TGA consultation hub.
What are the stand and end dates of the consultation?
Start Date: 28 February 2022
Ennd Date: 28 March 2022