Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process

Closed 1 Apr 2022

Opened 28 Feb 2022

Feedback updated 25 Nov 2022

We asked

We asked for feedback on a proposed priority review pathway for assessment of certain novel and life-saving biologicals. The proposal was to introduce a formal pathway for biologicals with shorter time from submission to ARTG inclusion, in alignment with the existing priority pathway for medicines. 

Feedback was sought on:

  • whether you support the introduction of a priority review pathway for biologicals
  • the proposed eligibility criteria for priority determination.
  • the proposed process for priority determination.

You said

We received 25 submissions in response to the consultation, 21 were received through Citizenspace and 4 were received through email. The respondents were from industry organisations and peak bodies, health professionals or heath professional organisations, consumer groups and individuals.

All respondents supported introduction of the proposed priority pathway, noting, this is a step in right direction and will improve timely access to lifesaving products and align biologicals with medicines.

There was general support for the proposed eligibility criteria with 72% respondents supporting it, but some comments raised concerns on the suitability of criteria for all classes of biological products, clarity around the terminology used, and the need for alignment with overseas regulators.

The proposed process for determination, timeframes, and the need to publish outcomes of determination decisions, decision summaries and AusPARs were supported by the respondents.

We did

We considered all submissions and have made minor changes to the wording of the eligibility criteria to address some of the concerns.

We have finalised the priority pathway for biologicals and made necessary legislative changes to enable its implementation. The pathway is now operational and can be utilised by Sponsors.  We have provided necessary guidance material on TGA website to assist sponsors interested in using this pathway.   

TGA will continue to work with PBAC and MSAC to align the accelerated ARTG inclusion of biologicals through the priority pathway with reimbursement schemes.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on a proposed priority pathway for assessment of certain novel and life-saving biologicals

The proposed 'Priority Review' pathway will align with the pathway in place for medicines and offer a faster formal assessment pathway for biologicals in certain circumstances. This will allow consumers with life-threatening diseases or seriously debilitating conditions to access these treatments in less time if the assessment results in a decision by the TGA to include the biological in the Australian Register of Therapeutic Goods (ARTG).

We are seeking feedback on:

  • whether you support the introduction of a priority pathway for biologicals
  • the proposed eligibility criteria for the Priority Review pathway for biologicals
  • the proposed process for determining whether a biological application meets the eligibility criteria for Priority Review (the ‘Determination Process’).

Consultation paper

This consultation paper outlines the proposed eligibility criteria, determination process and other considerations including fees and charges.

Consultation paper - Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process.

Making a submission

To make a submission:

  1. Read the consultation paper about the proposed Priority Review pathway (see link above).
  2. Go to the online consultation questions (see ‘Give us your views’ below), complete and submit your response.

Why your views matter

There is currently no formal mechanism to expedite the assessment and inclusion of biologicals in the ARTG.

We are seeking your input on whether a priority pathway should be established and, if so, if the proposed Priority Review pathway is suitable. We are seeking your feedback to make sure the proposed priority pathway:

  • assists in achieving faster assessment and earlier access to certain novel and life-saving biologicals that address unmet clinical needs for Australian consumers
  • provides 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
  • increases alignment with other overseas regulators that offer accelerated assessment processes.

What happens next

We will review all feedback received in response to this consultation.

Depending on the feedback received, the TGA could propose to the Australian Government that a priority pathway be implemented for the pre-market assessment and registration of novel biologicals that address unmet clinical needs for Australian consumers. This would require changes to the Therapeutic Goods Regulations 1990.

Audiences

  • Anyone from any background

Interests

  • Health technology
  • Legislation
  • Regulatory policy